Trial Outcomes & Findings for Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP (NCT NCT02923726)

Last Updated: 2024-10-22

Results Overview

The incidence of all-cause shocks in subjects programmed with shocks only will be compared with subjects programmed to standard therapy (ATP and shock) to assess equivalency. All shocks delivered by the device were adjudicated by an external committee as to whether they were appropriately or inappropriately delivered. All shocks, appropriate and inappropriate, contributed to the evaluation of this endpoint.

Recruitment status

COMPLETED

Study phase

Target enrollment

2692 participants

Primary outcome timeframe

5 years

Results posted on

2024-10-22

Participant Flow

Recruitment for participants began on 30 Sep 2016 and ended on 13 Apr 2021 when the adjudicated primary episode target had been met. Potential participants, located at medical clinics or hospitals, were eligible for the study if they were 21 years of age or older and had a Class 1 or IIA indication for primary prevention implantable cardioverter defibrillator (ICD) therapy with a low left ventricular ejection fraction. Participants were considered enrolled once consented.

Of the 2692 participants enrolled,19 were consent ineligible and 12 were intent and therefore not randomized. 2595 participants were randomized. Consented and Ineligible: Consent signed but eligibility criteria was not met at time of enrollment • Intent: All eligibility criteria met and consent signed, but participant was not randomized due to: * no longer meeting eligibility criteria at the time of randomization * no longer willing to participate in the study

Participant milestones

Participant milestones
Measure	ATP and Shock Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy. Arm 1 (ATP+Shock): Subjects will be randomized and device programmed to the respective arm.	Shock Only Once tachycardia has been detected and duration met, this group would receive shock therapy only. Arm 2 (shock only): Subjects will be randomized and device programmed to the respective arm.
Overall Study STARTED	1302	1293
Overall Study COMPLETED	769	811
Overall Study NOT COMPLETED	533	482

Reasons for withdrawal

Reasons for withdrawal
Measure	ATP and Shock Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy. Arm 1 (ATP+Shock): Subjects will be randomized and device programmed to the respective arm.	Shock Only Once tachycardia has been detected and duration met, this group would receive shock therapy only. Arm 2 (shock only): Subjects will be randomized and device programmed to the respective arm.
Overall Study Death	196	175
Overall Study Withdrawal by Subject	337	307

Baseline Characteristics

Data missing for one randomized subject in the ATP and Shock arm.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 5 years

Population: All randomized subjects.

Outcome measures

Outcome measures
Measure	ATP and Shock n=1302 Participants Receive antitachycardia pacing prior to shock therapy.	Shock Only n=1293 Participants Receive shock therapy only.
All-Cause Shock	129 Participants	178 Participants

SECONDARY outcome

Timeframe: 5 years

Population: All randomized subjects.

incidence of all-cause shocks or death from any cause

Outcome measures

Outcome measures
Measure	ATP and Shock n=1302 Participants Receive antitachycardia pacing prior to shock therapy.	Shock Only n=1293 Participants Receive shock therapy only.
All-Cause Shock or Death From Any Cause	297 Participants	322 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Randomized subjects.

incidence of first appropriate shock All shocks delivered by the device were adjudicated by an external committee as to whether they were appropriately or inappropriately delivered. Appropriate shocks contributed to the evaluation of this endpoint.

Outcome measures

Outcome measures
Measure	ATP and Shock n=1302 Participants Receive antitachycardia pacing prior to shock therapy.	Shock Only n=1293 Participants Receive shock therapy only.
Appropriate Shock	96 Participants	132 Participants

SECONDARY outcome

Timeframe: 5 years

Population: All randomized subjects.

incidence of first inappropriate shock All shocks delivered by the device were adjudicated by an external committee as to whether they were appropriately or inappropriately delivered. Inappropriate shocks contributed to the evaluation of this endpoint.

Outcome measures

Outcome measures
Measure	ATP and Shock n=1302 Participants Receive antitachycardia pacing prior to shock therapy.	Shock Only n=1293 Participants Receive shock therapy only.
Inappropriate Shock	40 Participants	62 Participants

SECONDARY outcome

Timeframe: 5 years

Population: All randomized subjects.

incidents of all cause mortality

Outcome measures

Outcome measures
Measure	ATP and Shock n=1302 Participants Receive antitachycardia pacing prior to shock therapy.	Shock Only n=1293 Participants Receive shock therapy only.
All Cause Mortality	196 Participants	174 Participants

Adverse Events

ATP and Shock

Serious events: 633 serious events

Other events: 420 other events

Deaths: 196 deaths

Shock Only

Serious events: 618 serious events

Other events: 448 other events

Deaths: 175 deaths

Serious adverse events

Other adverse events

Additional Information

Jacqueline Beaulieu, Sr. Clinical Trial Manager

Boston Scientific

Phone: 1-800-227-3422

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. Sponsor may extend the review period for another 90 days to take steps to protect its intellectual property interests, or to remove any language detrimental to Sponsor's intellectual property interests.
Publication restrictions are in place

Restriction type: OTHER

Measure	ATP and Shock n=1302 Participants Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy. Arm 1 (ATP+Shock): Subjects will be randomized and device programmed to the respective arm.	Shock Only n=1293 Participants Once tachycardia has been detected and duration met, this group would receive shock therapy only. Arm 2 (shock only): Subjects will be randomized and device programmed to the respective arm.	Total n=2595 Participants Total of all reporting groups
Age, Continuous	64.0 Years STANDARD_DEVIATION 11.5 • n=1302 Participants	63.8 Years STANDARD_DEVIATION 11.1 • n=1293 Participants	63.9 Years STANDARD_DEVIATION 11.3 • n=2595 Participants
Sex: Female, Male Female	277 Participants n=1301 Participants • Data missing for one randomized subject in the ATP and Shock arm.	304 Participants n=1293 Participants • Data missing for one randomized subject in the ATP and Shock arm.	581 Participants n=2594 Participants • Data missing for one randomized subject in the ATP and Shock arm.
Sex: Female, Male Male	1024 Participants n=1301 Participants • Data missing for one randomized subject in the ATP and Shock arm.	989 Participants n=1293 Participants • Data missing for one randomized subject in the ATP and Shock arm.	2013 Participants n=2594 Participants • Data missing for one randomized subject in the ATP and Shock arm.
Race/Ethnicity, Customized Race · American Indian or Alaksa Native	5 Participants n=1287 Participants • Data was not reported for 26 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	8 Participants n=1282 Participants • Data was not reported for 26 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	13 Participants n=2569 Participants • Data was not reported for 26 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.
Race/Ethnicity, Customized Race · Asian	209 Participants n=1287 Participants • Data was not reported for 26 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	206 Participants n=1282 Participants • Data was not reported for 26 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	415 Participants n=2569 Participants • Data was not reported for 26 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.
Race/Ethnicity, Customized Race · Black or African Heritage	169 Participants n=1287 Participants • Data was not reported for 26 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	178 Participants n=1282 Participants • Data was not reported for 26 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	347 Participants n=2569 Participants • Data was not reported for 26 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.
Race/Ethnicity, Customized Race · Caucasian	860 Participants n=1287 Participants • Data was not reported for 26 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	849 Participants n=1282 Participants • Data was not reported for 26 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	1709 Participants n=2569 Participants • Data was not reported for 26 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.
Race/Ethnicity, Customized Race · Hispanic or Latino	39 Participants n=1287 Participants • Data was not reported for 26 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	37 Participants n=1282 Participants • Data was not reported for 26 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	76 Participants n=2569 Participants • Data was not reported for 26 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	2 Participants n=1287 Participants • Data was not reported for 26 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	3 Participants n=1282 Participants • Data was not reported for 26 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	5 Participants n=2569 Participants • Data was not reported for 26 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.
Race/Ethnicity, Customized Race · Other	3 Participants n=1287 Participants • Data was not reported for 26 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	1 Participants n=1282 Participants • Data was not reported for 26 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	4 Participants n=2569 Participants • Data was not reported for 26 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.
Region of Enrollment Canada	141 Participants n=1294 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	151 Participants n=1284 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	292 Participants n=2578 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.
Region of Enrollment Austria	13 Participants n=1302 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	15 Participants n=1293 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	28 Participants n=2595 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.
Region of Enrollment South Korea	123 Participants n=1302 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	129 Participants n=1293 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	252 Participants n=2595 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.
Region of Enrollment United States	841 Participants n=1302 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	823 Participants n=1293 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	1664 Participants n=2595 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.
Region of Enrollment Japan	65 Participants n=1302 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	60 Participants n=1293 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	125 Participants n=2595 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.
Region of Enrollment Italy	71 Participants n=1302 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	71 Participants n=1293 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	142 Participants n=2595 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.
Region of Enrollment United Kingdom	20 Participants n=1302 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	17 Participants n=1293 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	37 Participants n=2595 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.
Region of Enrollment Spain	20 Participants n=1302 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	18 Participants n=1293 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.	38 Participants n=2595 Participants • Data was not reported for 17 subjects. The total number analyzed for both arms has been adjusted to remove these subjects.
History of Atrial Fibrillation Permanent Atrial Fibrillation	70 Participants n=1302 Participants	56 Participants n=1293 Participants	126 Participants n=2595 Participants
History of Atrial Fibrillation Persistent Atrial Fibrillation	95 Participants n=1302 Participants	92 Participants n=1293 Participants	187 Participants n=2595 Participants
History of Atrial Fibrillation Paroxysmal Atrial Fibrillation	176 Participants n=1302 Participants	208 Participants n=1293 Participants	384 Participants n=2595 Participants
History of Atrial Fibrillation No History of Atrial Fibrillation	961 Participants n=1302 Participants	937 Participants n=1293 Participants	1898 Participants n=2595 Participants
Etiology Ischemic	757 Participants n=1302 Participants	753 Participants n=1293 Participants	1510 Participants n=2595 Participants
Etiology Non-ischemic	545 Participants n=1302 Participants	540 Participants n=1293 Participants	1085 Participants n=2595 Participants
Diabetes	525 Participants n=1302 Participants	520 Participants n=1293 Participants	1045 Participants n=2595 Participants
Device Type Single Chamber ICD	678 Participants n=1300 Participants • Data was missing for one subject in the Shock Only arm and two subjects in the ATP +Shock arm.	646 Participants n=1292 Participants • Data was missing for one subject in the Shock Only arm and two subjects in the ATP +Shock arm.	1324 Participants n=2592 Participants • Data was missing for one subject in the Shock Only arm and two subjects in the ATP +Shock arm.
Device Type Dual Chamber ICD	622 Participants n=1300 Participants • Data was missing for one subject in the Shock Only arm and two subjects in the ATP +Shock arm.	646 Participants n=1292 Participants • Data was missing for one subject in the Shock Only arm and two subjects in the ATP +Shock arm.	1268 Participants n=2592 Participants • Data was missing for one subject in the Shock Only arm and two subjects in the ATP +Shock arm.
Indication Myocardial Infarction (MI) and Ejection Fraction (EF) >/= 30%	417 Participants n=1302 Participants	445 Participants n=1293 Participants	862 Participants n=2595 Participants
Indication New York Heart Association (NYHA) Class II/III and EF </= 35%	876 Participants n=1302 Participants	842 Participants n=1293 Participants	1718 Participants n=2595 Participants
Indication Other	9 Participants n=1302 Participants	6 Participants n=1293 Participants	15 Participants n=2595 Participants

Serious adverse events
Measure	ATP and Shock n=1302 participants at risk Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy. Arm 1 (ATP+Shock): Subjects will be randomized and device programmed to the respective arm.	Shock Only n=1293 participants at risk Once tachycardia has been detected and duration met, this group would receive shock therapy only. Arm 2 (shock only): Subjects will be randomized and device programmed to the respective arm.
Cardiac disorders Pulseless Electrical Activity (PEA)	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Unable to capture - RA PG System	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Elevated threshold - RV PG System	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Impedance Out of Range - RV PG System	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Undersensing - Defibrillation - PG System	0.15% 2/1302 • Number of events 2 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Elevated DFT - Defibrillation - PG System	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Inappropriate Tachy Therapy - SVT - PG System Therapy	1.00% 13/1302 • Number of events 14 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	1.3% 17/1293 • Number of events 18 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Infections and infestations Infection (>30 days post-implant) - PG System - Subject related	0.69% 9/1302 • Number of events 9 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.54% 7/1293 • Number of events 7 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Psychiatric disorders Twiddler's Syndrome - PG System - Subject related	0.15% 2/1302 • Number of events 2 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Injury, poisoning and procedural complications Migration - PG System - Subject related	0.15% 2/1302 • Number of events 2 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Injury, poisoning and procedural complications Post-surgical wound discomfort/bruising/swelling	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Injury, poisoning and procedural complications Post-surgical infection (<=30 days post-implant)	0.38% 5/1302 • Number of events 5 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.23% 3/1293 • Number of events 3 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Injury, poisoning and procedural complications Chest pain	0.15% 2/1302 • Number of events 2 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Injury, poisoning and procedural complications Hematoma - Pocket (<=30 days post-implant)	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Injury, poisoning and procedural complications Death-Unknown - PG System - Procedure	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Injury, poisoning and procedural complications Deep Vein Thrombosis - PG System - Procedure	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Unable to capture - RA Lead	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Conductor coil fracture - RA Lead	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Myocardial perforation post-implant - RA Lead	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Dislodgment - Multiple signs - RA Lead	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Dislodgment - No reported signs - RA Lead	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Thrombosis - Lead	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Tricuspid Valve Damage RV lead - Lead	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Unable to capture - RV Lead	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Extracardiac stimulation - RV Lead	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Conductor coil fracture - RV Lead	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Myocardial perforation post-implant - RV Lead	0.15% 2/1302 • Number of events 2 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.15% 2/1293 • Number of events 2 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Dislodgment - Unable to capture - RV Lead	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.15% 2/1293 • Number of events 2 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Dislodgment - Elevated threshold -RV Lead	0.15% 2/1302 • Number of events 2 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.23% 3/1293 • Number of events 3 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Dislodgment - Oversensing - RV Lead	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Dislodgment - Multiple signs - RV Lead	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Dislodgment - No reported signs - RV Lead	0.15% 2/1302 • Number of events 2 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Impedance Out of Range - Defibrillation lead	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Injury, poisoning and procedural complications Pneumothorax - Procedure	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Injury, poisoning and procedural complications Pericardial effusion - Procedure	0.08% 1/1302 • Number of events 2 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.15% 2/1293 • Number of events 2 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Cardiac disorders 3rd degree AV block	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Cardiac disorders Sinus bradycardia	0.23% 3/1302 • Number of events 3 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.31% 4/1293 • Number of events 4 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Cardiac disorders Ventricular Fibrillation (VF)	1.8% 24/1302 • Number of events 25 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	2.1% 27/1293 • Number of events 30 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Cardiac disorders Ventricular Tachycardia (VT)/Monomorphic VT	3.3% 43/1302 • Number of events 71 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	3.8% 49/1293 • Number of events 57 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Cardiac disorders Nonsustained Ventricular Tachycardia (NSVT)	0.23% 3/1302 • Number of events 3 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.23% 3/1293 • Number of events 3 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator

Other adverse events
Measure	ATP and Shock n=1302 participants at risk Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy. Arm 1 (ATP+Shock): Subjects will be randomized and device programmed to the respective arm.	Shock Only n=1293 participants at risk Once tachycardia has been detected and duration met, this group would receive shock therapy only. Arm 2 (shock only): Subjects will be randomized and device programmed to the respective arm.
Product Issues Oversensing - RA PG System	0.15% 2/1302 • Number of events 2 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Undersensing - RA PG System	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Oversensing - RV PG System	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Impedance Out of Range - RV PG System	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Oversensing - Defibrillation - PG System	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Inappropriate Tachy Therapy - SVT - PG System Therapy	1.5% 20/1302 • Number of events 25 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	3.1% 40/1293 • Number of events 57 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Early ERI - Premature declaration - PG System Therapy	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Pacemaker Mediated Tachycardia - PG System Therapy	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.31% 4/1293 • Number of events 4 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Injury, poisoning and procedural complications Inadequate healing of incision site - PG System - Subject related	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Psychiatric disorders Psychological effect due to device therapy - PG System - Subject related	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Psychiatric disorders Twiddler's Syndrome - PG System - Subject related	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Injury, poisoning and procedural complications Migration - PG System - Subject related	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Complex Regional Pain Syndrome and Frozen Shoulder - PG System - Patient Related	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Pain at Site - PG System - Patient Related	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Injury, poisoning and procedural complications Post-surgical wound discomfort/bruising/swelling	0.23% 3/1302 • Number of events 3 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.31% 4/1293 • Number of events 4 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Injury, poisoning and procedural complications Post-surgical infection (<=30 days post-implant)	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.23% 3/1293 • Number of events 3 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Injury, poisoning and procedural complications Hematoma - Pocket (<=30 days post-implant)	0.15% 2/1302 • Number of events 2 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.23% 3/1293 • Number of events 3 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Injury, poisoning and procedural complications Thromboembolic events	0.15% 2/1302 • Number of events 2 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Oversensing - RA Lead	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.15% 2/1293 • Number of events 2 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Undersensing - RA Lead	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Unable to capture - RA Lead	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Elevated threshold - RA Lead	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Extracardiac stimulation - RA Lead	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Conductor coil fracture - RA Lead	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Dislodgment - Elevated threshold - RA Lead	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Dislodgment - Multiple signs - RA Lead	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Dislodgment - No reported signs - RA Lead	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Oversensing - RV Lead	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Elevated threshold - RV Lead	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Extracardiac stimulation - RV Lead	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Conductor coil fracture - RV Lead	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Insulation breach - RV Lead	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Dislodgment - Unable to capture - RV Lead	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Dislodgment - Elevated threshold -RV Lead	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.23% 3/1293 • Number of events 4 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Dislodgment - Undersensing - RV Lead	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Dislodgment - No reported signs - RV Lead	0.15% 2/1302 • Number of events 2 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Product Issues Impedance Out of Range - Defibrillation lead	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Injury, poisoning and procedural complications Pneumothorax - Procedure	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Injury, poisoning and procedural complications Pericardial effusion - Procedure	0.08% 1/1302 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.00% 0/1293 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator
Injury, poisoning and procedural complications Attempted coronary sinus lead placement - Lead - Procedure	0.00% 0/1302 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator	0.08% 1/1293 • Number of events 1 • Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months. Adverse events and deaths occurring after 5 years of follow-up are included; therefore, there may be more events reported here than in the endpoints. Acronyms: RA: right atrial PG: pulse generator RV: right ventricle DFT: defibrillation threshold testing SVT: supraventricular tachycardia AVRT: atrioventricular reentrant tachycardia AVNRT: atrioventricular nodal reentrant tachycardia EAT: ectopic atrial tachycardia ERI: elective replacement indicator