Trial Outcomes & Findings for REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE) (NCT NCT00271154)

NCT ID: NCT00271154

Last Updated: 2012-01-30

Results Overview

Patients considered worsened if they died, were hospitalized with worsening heart failure (HF), crossed over to other arm, demonstrated worsening in New York Heart Association (NYHA) functional class, or reported moderately/markedly worse HF symptoms compared to before CRT implant.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 684 participants
• Primary outcome timeframe: 12 Months
• Results posted on: 2012-01-30

Participant Flow

Patients were enrolled from September 2004 through September 2006 at 73 sites located in the United States, Canada, and Europe.

A total of 684 patients were enrolled in the study. Of these, 642 patients were attempted for cardiac resynchronization therapy (CRT) device implant. 21 were unsuccessful, leaving 621 patients successfully implanted with a CRT device. Of these 621 patients, 610 were randomized.

Participant milestones

Measure	CRT OFF Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy	CRT ON Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
Overall Study STARTED	191	419
Overall Study COMPLETED	191	419
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)

Baseline characteristics by cohort

Measure	CRT OFF n=191 Participants Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy	CRT ON n=419 Participants Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy	Total n=610 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	108 Participants n=5 Participants	229 Participants n=7 Participants	337 Participants n=5 Participants
Age, Categorical >=65 years	83 Participants n=5 Participants	190 Participants n=7 Participants	273 Participants n=5 Participants
Age Continuous	61.8 years STANDARD_DEVIATION 11.6 • n=5 Participants	62.9 years STANDARD_DEVIATION 10.6 • n=7 Participants	62.5 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	92 Participants n=7 Participants	131 Participants n=5 Participants
Sex: Female, Male Male	152 Participants n=5 Participants	327 Participants n=7 Participants	479 Participants n=5 Participants
Region of Enrollment United States	108 participants n=5 Participants	235 participants n=7 Participants	343 participants n=5 Participants
Region of Enrollment Spain	9 participants n=5 Participants	18 participants n=7 Participants	27 participants n=5 Participants
Region of Enrollment Ireland	1 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Austria	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment United Kingdom	6 participants n=5 Participants	9 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment Italy	5 participants n=5 Participants	12 participants n=7 Participants	17 participants n=5 Participants
Region of Enrollment France	15 participants n=5 Participants	34 participants n=7 Participants	49 participants n=5 Participants
Region of Enrollment Czech Republic	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Hungary	6 participants n=5 Participants	13 participants n=7 Participants	19 participants n=5 Participants
Region of Enrollment Canada	1 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Belgium	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Denmark	19 participants n=5 Participants	46 participants n=7 Participants	65 participants n=5 Participants
Region of Enrollment Germany	6 participants n=5 Participants	11 participants n=7 Participants	17 participants n=5 Participants
Region of Enrollment Norway	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Sweden	7 participants n=5 Participants	17 participants n=7 Participants	24 participants n=5 Participants
Region of Enrollment Netherlands	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Months

Population: All randomized patients were included using Intent to Treat (ITT).

Patients considered worsened if they died, were hospitalized with worsening heart failure (HF), crossed over to other arm, demonstrated worsening in New York Heart Association (NYHA) functional class, or reported moderately/markedly worse HF symptoms compared to before CRT implant.

Outcome measures

Measure	CRT OFF n=191 Participants Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy	CRT ON n=419 Participants Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
Percentage of Patients Worsened for Clinical Composite Response	21.5 Percentage of participants worsened	16 Percentage of participants worsened

SECONDARY outcome

Timeframe: Baseline to 12 months

The change is LVESVi measured at 12 months minus LVESVi measured at baseline. The 12-month echocardiographic measurements were made with CRT programmed off, irespective of the treatment assignment. In CRT ON patients these measurements were recorded after a 10 minute washout period. Two core laboratories performed all echo measurements.

Outcome measures

Measure	CRT OFF n=191 Participants Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy	CRT ON n=419 Participants Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
Change in Left Ventricular End Systolic Volume, Indexed (LVESVi)	-1.3 milliliters per meters squared Standard Deviation 23.4	-18.4 milliliters per meters squared Standard Deviation 29.5

Adverse Events

CRT OFF

Serious events: 122 serious events

Other events: 61 other events

Deaths: 0 deaths

CRT ON

Serious events: 268 serious events

Other events: 140 other events

Deaths: 0 deaths

Not Randomized

Serious events: 13 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	CRT OFF n=119 participants at risk；n=191 participants at risk Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy	CRT ON n=491 participants at risk；n=419 participants at risk Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy	Not Randomized n=38 participants at risk These patients were enrolled in the study, but not randomized to CRT ON or CRT OFF. Their adverse events were collected until they exited the study.
General disorders Cardiac failure acute	15.7% 30/191 • Number of events 52 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	13.4% 56/419 • Number of events 98 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	5.3% 2/38 • Number of events 5 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Medical device change	9.9% 19/191 • Number of events 19 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	10.7% 45/419 • Number of events 46 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Ventricular tachycardia	5.8% 11/191 • Number of events 14 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	7.2% 30/419 • Number of events 43 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders LV lead dislodgement	6.8% 13/191 • Number of events 15 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	6.2% 26/419 • Number of events 28 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	5.3% 2/38 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Chest pain	2.1% 4/191 • Number of events 4 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	5.0% 21/419 • Number of events 25 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Pneumonia	4.2% 8/191 • Number of events 9 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	3.8% 16/419 • Number of events 19 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Atrial fibrillation	4.2% 8/191 • Number of events 8 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	3.6% 15/419 • Number of events 19 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Device lead damage	4.2% 8/191 • Number of events 8 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	4.3% 18/419 • Number of events 18 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Inappropriate device therapy	1.6% 3/191 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	3.8% 16/419 • Number of events 16 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Ventricular fibrillation	2.1% 4/191 • Number of events 4 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	1.9% 8/419 • Number of events 11 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Cardiac failure chronic	2.6% 5/191 • Number of events 6 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	1.2% 5/419 • Number of events 6 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	5.3% 2/38 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Chronic obstructive pulmonary disease	1.6% 3/191 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	1.7% 7/419 • Number of events 11 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders RV lead dislodgement	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	3.1% 13/419 • Number of events 13 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Syncope	2.6% 5/191 • Number of events 7 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	1.2% 5/419 • Number of events 5 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Angina pectoris	2.1% 4/191 • Number of events 4 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	1.9% 8/419 • Number of events 8 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Atrial flutter	3.1% 6/191 • Number of events 6 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.95% 4/419 • Number of events 5 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Inappropriate device irritation of tissue	1.6% 3/191 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.1% 9/419 • Number of events 9 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Cerebrovascular accident	2.1% 4/191 • Number of events 5 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	1.2% 5/419 • Number of events 6 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Gastrointestinal hemorrhage	3.1% 6/191 • Number of events 6 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.95% 4/419 • Number of events 5 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Hypotension	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.1% 9/419 • Number of events 9 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Dyspnea	1.0% 2/191 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	1.7% 7/419 • Number of events 7 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Failure to capture	2.6% 5/191 • Number of events 6 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.95% 4/419 • Number of events 4 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Lead dislodgement	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	1.9% 8/419 • Number of events 10 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders RA lead dislodgement	1.0% 2/191 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	1.9% 8/419 • Number of events 8 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Renal failure acute	2.1% 4/191 • Number of events 4 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	1.4% 6/419 • Number of events 6 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Transient ischemic attack	1.0% 2/191 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	1.9% 8/419 • Number of events 8 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Coronary artery disease	2.1% 4/191 • Number of events 5 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.72% 3/419 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Carotid artery stenosis	1.0% 2/191 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	1.2% 5/419 • Number of events 5 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Implant site hematoma	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	1.4% 6/419 • Number of events 6 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Myocardial infarction	1.6% 3/191 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.95% 4/419 • Number of events 4 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Osteoarthritis	1.0% 2/191 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	1.2% 5/419 • Number of events 5 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Pneumothorax	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	1.2% 5/419 • Number of events 6 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Acute myocardial infarction	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.95% 4/419 • Number of events 4 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Atrial tachycardia	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.72% 3/419 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Ischemic stroke	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.72% 3/419 • Number of events 5 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Pericardial effusion	1.0% 2/191 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.72% 3/419 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Peripheral vascular disorder	0.52% 1/191 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Renal failure	1.0% 2/191 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.72% 3/419 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Sudden cardiac death	1.0% 2/191 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.72% 3/419 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Acute pulmonary edema	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.72% 3/419 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Anemia	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.95% 4/419 • Number of events 4 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Asthma	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Atrioventricular block complete	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	7.9% 3/38 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Bradycardia	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.72% 3/419 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Bronchitis	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.72% 3/419 • Number of events 4 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Cardiac arrest	1.0% 2/191 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Cholecystitis acute	1.0% 2/191 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Deep vein thrombosis	1.0% 2/191 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Implant site infection	1.0% 2/191 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Inappropriate device signal detection	1.6% 3/191 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Ischemic cardiomyopathy	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Lung neoplasm malignant	1.0% 2/191 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Respiratory failure	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.72% 3/419 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Acute respiratory failure	1.0% 2/191 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Angina unstable	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.72% 3/419 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Aortic aneurysm	1.0% 2/191 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Atrioventricular block third degree	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Back pain	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Bronchitis acute	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.72% 3/419 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Cardiac perforation	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Cardiac tamponade	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Contusion	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Defibrillation threshold increased	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Dehydration	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Dizziness	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Esophageal carcinoma	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.72% 3/419 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Hematoma	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.72% 3/419 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Intracardiac thrombus	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Myocardial ischemia	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Non-cardiac chest pain	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.72% 3/419 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Pericarditis	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Presyncope	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Prostate examination abnormal	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.72% 3/419 • Number of events 3 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Pulmonary edema	1.0% 2/191 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Subclavian vein thrombosis	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Therapeutic agent toxicity	0.52% 1/191 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Anxiety	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Aortic stenosis	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Arrhythmia supraventricular	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Arteriovenous fistula	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Biliary colic	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Cholecystitis	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Cholelithiasis	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Coronary artery dissection	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Coronary artery stenosis	1.0% 2/191 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Death	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Edema peripheral	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Diabetes mellitus	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Diabetes mellitus inadequate control	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Drug hypersensitivity	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Drug toxicity	0.52% 1/191 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Dyspnea exertional	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Electromechanical dissociation	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Fatigue	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Heart transplant	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Hyperglycemia	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Inappropriate device stimulation of tissue	1.0% 2/191 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Mental status changes	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Mitral valve incompetence	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Orthostatic hypotension	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Oversensing	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Paraesthesia	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Pneumonia aspiration	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Postoperative wound infection	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Pulmonary embolism	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Pulmonary fibrosis	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Sepsis	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Syncope vasovagal	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Tachycardia	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Urinary tract infection	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.48% 2/419 • Number of events 2 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Abdominal abscess	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Abdominal discomfort	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Abdominal pain upper	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Acute coronary syndrome	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Adverse drug reaction	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Ankle fracture	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Anorexia	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Anxiety disorder	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Aortic thrombosis	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Arrhythmia	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Arterial disorder	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Arterial stenosis	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Arteriogram coronary	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Arteriopathic disease	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Arthralgia	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Asthenia	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Bacteraemia	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Balance disorder	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Biopsy liver	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Bronchopulmonary aspergillosis	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Cardiac ablation	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Cardiac failure	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Cardiac procedure complication	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Cardio-renal syndrome	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Cardiomyopathy	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Cardiomyopathy alcoholic	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Cellulitis	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Cervical dysplasia	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Chest discomfort	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Colon cancer	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Colonic obstruction	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Colostomy	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Constipation	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Contrast media reaction	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Convulsion	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Coronary artery restenosis	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Decreased RV Sensing	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Depressed level of consciousness	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Device electrical finding	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Device migration	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Device related infection	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Elevated pacing threshold	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Diabetes mellitus insulin-dependent	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Dislodgement of LV lead	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Diverticulitis esophageal	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Duodenal ulcer	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Endocarditis	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Epistaxis	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Extrasystoles	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Fluid overload	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Gastroenteritis	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders General physical health deterioration	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Goiter	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Hairy cell leukemia	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Headache	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Hematoma evacuation	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Hemianopsia homonymous	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Hemoglobin decreased	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Hemorrhage	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Hemorrhoids	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Hepatic function abnormal	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Hip arthroplasty	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Hypersensitivity	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Hyperthyroidism	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Hypervolemic	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Hypoglycemia	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Hypokalemia	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Hyponatremia	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Hypothyroidism	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Hypoxia	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Implant site erosion	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Implant site inflammation	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Implant site irritation	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders In-stent arterial restenosis	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Incision site complication	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Infection	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Inguinal hernia repair	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Intermittent claudication	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Intestinal obstruction	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Iodine allergy	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Joint dislocation	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Joint swelling	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Knee arthroplasty	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Leukothrombopenia	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Low cardiac output syndrome	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Lower respiratory tract infection	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Lower respiratory tract infection viral	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Lumbar spinal stenosis	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Lung adenocarcinoma	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Lung consolidation	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Malaise	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Medical device complication	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Melaena	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Metastases to bone	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Metastatic neoplasm	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Mitral valve disease	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Mitral valve repair	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Multi-organ failure	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Musculoskeletal chest pain	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Neoplasm malignant	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Nephrolithiasis	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Nodal arrhythmia	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Orthostatic intolerance	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Oxygen saturation decreased	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Palpitations	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Perianal abscess	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Peripheral arterial occlusive disease	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Peripheral ischemia	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Phlebitis	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Pituitary tumor	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Pleural effusion	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Polyneuropathy	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Prostate cancer	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Pulmonary hypertension	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Pulmonary mass	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Rectal hemorrhage	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Renal cancer metastatic	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Renal impairment	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Retinal detachment	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Retroperitoneal hemorrhage	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Sinusitis	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Skin irritation	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Skin ulcer	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Small cell lung cancer stage unspecified	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Small intestinal obstruction	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Spondylolysis	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Squamous cell carcinoma	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Subarachnoid hemorrhage	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Subdural hematoma	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Supraventricular tachycardia	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Throat lesion	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Thrombocytopenia	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Tonsillar disorder	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Tooth disorder	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Twiddler's syndrome	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Urinary bladder adenoma	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Valvuloplasty cardiac	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Vascular pseudoaneurysm	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Venous stenosis	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Ventricular arrhythmia	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Ventricular assist device insertion	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Vertigo CNS origin	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Vestibular neuronitis	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Viral infection	0.52% 1/191 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/419 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Vocal cord polyp	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Vocal cord thickening	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Wound dehiscence	0.00% 0/191 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.24% 1/419 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.

Other adverse events

Measure	CRT OFF n=119 participants at risk；n=191 participants at risk Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy	CRT ON n=491 participants at risk；n=419 participants at risk Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy	Not Randomized n=38 participants at risk These patients were enrolled in the study, but not randomized to CRT ON or CRT OFF. Their adverse events were collected until they exited the study.
General disorders Cardiac failure chronic	20.2% 24/119 • Number of events 30 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	6.3% 31/491 • Number of events 35 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Atrial fibrillation	6.7% 8/119 • Number of events 8 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	9.6% 47/491 • Number of events 57 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Dizziness	7.6% 9/119 • Number of events 9 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	5.1% 25/491 • Number of events 29 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Inappropriate device stimulation of tissue	9.2% 11/119 • Number of events 12 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	4.3% 21/491 • Number of events 25 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Inappropriate device irritation of tissue	3.4% 4/119 • Number of events 4 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	5.3% 26/491 • Number of events 30 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	2.6% 1/38 • Number of events 1 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Hypotension	8.4% 10/119 • Number of events 12 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	3.3% 16/491 • Number of events 16 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.
General disorders Fatigue	10.1% 12/119 • Number of events 12 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	3.1% 15/491 • Number of events 15 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.	0.00% 0/38 • Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10. Serious definition * Led to a death, * Led to a serious deterioration in health that resulted in: * a life-threatening illness or injury, * a permanent impairment of a body structure or function * hosp. or prolongation of existing hosp. * medical or surgical intervention to prevent permanent impairment to body structure or a body function.

Additional Information

CRDM Core Clinical

Medtronic CRDM

Phone: 800-328-2518

Email: medtroniccrmtrials@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee In most cases, contracts allow investigators to publish study results per the publication plan/protocol following Medtronic's review to determine whether confidential information ("CI") is disclosed. Any such CI is deleted prior to publication/presentation. Medtronic may not censor/interfere with the publication except as described. Investigators may not publish any single-site publications until the main multi-site study publication has occurred.
• Publication restrictions are in place

Restriction type: OTHER