Trial Outcomes & Findings for The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker (NCT NCT02030418)
NCT ID: NCT02030418
Last Updated: 2025-07-09
Results Overview
Complication is any device-or-procedure related serious adverse event, or serious adverse device effect, including those that prevented initial implantation. Percentage of participants free from complications are reported
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
952 participants
Primary outcome timeframe
6 months
Results posted on
2025-07-09
Participant Flow
Participant milestones
| Measure |
Leadless Pacemaker
VVIR pacing
Leadless Pacemaker: Patients will undergo an attempted leadless pacemaker implant
|
|---|---|
|
Overall Study
STARTED
|
952
|
|
Overall Study
Successful Implants
|
917
|
|
Overall Study
2-Week Visit
|
904
|
|
Overall Study
6-Week Visit
|
884
|
|
Overall Study
3-Month Visit
|
869
|
|
Overall Study
6-Month Visit
|
844
|
|
Overall Study
COMPLETED
|
808
|
|
Overall Study
NOT COMPLETED
|
144
|
Reasons for withdrawal
| Measure |
Leadless Pacemaker
VVIR pacing
Leadless Pacemaker: Patients will undergo an attempted leadless pacemaker implant
|
|---|---|
|
Overall Study
Death
|
78
|
|
Overall Study
Missed 12-Month Visit
|
9
|
|
Overall Study
Withdrawn
|
57
|
Baseline Characteristics
850 patients reporting LV ejection fraction data
Baseline characteristics by cohort
| Measure |
Leadless Pacemaker
n=952 Participants
VVIR pacing
Leadless Pacemaker: Patients will undergo an attempted leadless pacemaker implant
|
|---|---|
|
Age, Continuous
|
75.4 years
STANDARD_DEVIATION 12.6 • n=952 Participants
|
|
Sex: Female, Male
Female
|
359 Participants
n=952 Participants
|
|
Sex: Female, Male
Male
|
593 Participants
n=952 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
36 Participants
n=952 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
913 Participants
n=952 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=952 Participants
|
|
Race/Ethnicity, Customized
Asian
|
22 Participants
n=952 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
61 Participants
n=952 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
862 Participants
n=952 Participants
|
|
Race/Ethnicity, Customized
Other (Not Specified)
|
4 Participants
n=952 Participants
|
|
Race/Ethnicity, Customized
American Indian / Alaska Native
|
3 Participants
n=952 Participants
|
|
Region of Enrollment
Canada
|
101 participants
n=952 Participants
|
|
Region of Enrollment
United States
|
827 participants
n=952 Participants
|
|
Region of Enrollment
Australia
|
24 participants
n=952 Participants
|
|
Pacemaker Indication
Chronic AF with 2nd or 3rd Degree AV Block or Bundle Branch Block, including slow ventricular rates
|
529 Participants
n=952 Participants
|
|
Pacemaker Indication
Sinus Rhythm with 2nd or 3rd Degree AV Block or Byundle Branch Block
|
96 Participants
n=952 Participants
|
|
Pacemaker Indication
Sinus Bradycardia with Infrequent Pauses or Unexplained Syncope
|
330 Participants
n=952 Participants
|
|
LV Ejection Fraction
|
57.9 percentage
STANDARD_DEVIATION 8.1 • n=850 Participants • 850 patients reporting LV ejection fraction data
|
|
Congestive Heart Failure
|
149 Participants
n=952 Participants
|
|
NYHA Class
Class I
|
34 participants
n=149 Participants • NYHA Class evaluated for patients with congestive heart failure
|
|
NYHA Class
Class II
|
57 participants
n=149 Participants • NYHA Class evaluated for patients with congestive heart failure
|
|
NYHA Class
Class III
|
21 participants
n=149 Participants • NYHA Class evaluated for patients with congestive heart failure
|
|
NYHA Class
Not Done
|
37 participants
n=149 Participants • NYHA Class evaluated for patients with congestive heart failure
|
|
Hypertension
Controlled with Medication(s)
|
690 participants
n=736 Participants • 736 patients reporting hypertension
|
|
Hypertension
Uncontrolled
|
45 participants
n=736 Participants • 736 patients reporting hypertension
|
|
Hypertension
Controlled Without Medication(s)
|
1 participants
n=736 Participants • 736 patients reporting hypertension
|
|
Diabetes
Type I
|
14 participants
n=242 Participants • 242 patients reporting diabetes
|
|
Diabetes
Type II
|
228 participants
n=242 Participants • 242 patients reporting diabetes
|
|
Diabetes Current Status
Controlled with Diet
|
44 participants
n=242 Participants • 242 patients reporting diabetes
|
|
Diabetes Current Status
Controlled with Medication(s)
|
191 participants
n=242 Participants • 242 patients reporting diabetes
|
|
Diabetes Current Status
Uncontrolled
|
7 participants
n=242 Participants • 242 patients reporting diabetes
|
|
Hyperlipidemia
Hyperlipidemia Controlled with Diet
|
90 participants
n=615 Participants • 615 patients reporting hyperlipidemia
|
|
Hyperlipidemia
Hyperlipidemia Controlled with Medication(s)
|
509 participants
n=615 Participants • 615 patients reporting hyperlipidemia
|
|
Hyperlipidemia
Uncontrolled Hyperlipidemia
|
16 participants
n=615 Participants • 615 patients reporting hyperlipidemia
|
|
Peripheral Vascular Disease
|
113 participants
n=952 Participants
|
|
Cardiac Pulmonary History
Coronary Artery Disease
|
334 participants
n=952 Participants
|
|
Cardiac Pulmonary History
Myocardial Infarction
|
127 participants
n=952 Participants
|
|
Cardiac Pulmonary History
Unstable Angina
|
25 participants
n=952 Participants
|
|
Cardiac Pulmonary History
Prior PTCA / Stents / Atherectomy
|
144 participants
n=952 Participants
|
|
Cardiac Pulmonary History
Prior CABG
|
129 participants
n=952 Participants
|
|
Prior Ablation
AV Nodal
|
17 participants
n=952 Participants
|
|
Prior Ablation
AFib / Aflutter
|
78 participants
n=952 Participants
|
|
Prior Ablation
VT
|
2 participants
n=952 Participants
|
|
Prior Ablation
Mini Maze, Thorascope / LAA Ligation
|
2 participants
n=952 Participants
|
|
Prior Ablation
SVT/AVNRT Ablation
|
12 participants
n=952 Participants
|
|
Prior Ablation
Wolff-Parkinson-White Syndrome
|
2 participants
n=952 Participants
|
|
Prior Ablation
Unkown
|
1 participants
n=952 Participants
|
|
Tricuspid Valve Disease
Insufficiency / Prolapse / Regurgitation
|
184 participants
n=952 Participants
|
|
Tricuspid Valve Disease
Repair / Replacement
|
7 participants
n=952 Participants
|
|
Arrhythmia History
Ventricular
|
43 participants
n=952 Participants
|
|
Arrhythmia History
Non-Ventricular / Supraventricular
|
727 participants
n=952 Participants
|
|
Medications
Antiarrhythmics (Class I)
|
18 participants
n=952 Participants
|
|
Medications
Antiarrhythmics (Class III)
|
62 participants
n=952 Participants
|
|
Medications
Anticoagulants
|
571 participants
n=952 Participants
|
|
Medications
Antiplatelets
|
407 participants
n=952 Participants
|
|
Medications
ACE Inhibitors
|
249 participants
n=952 Participants
|
|
Medications
Angiotensin Receptor Blockers
|
167 participants
n=952 Participants
|
|
Medications
Beta Blockers
|
357 participants
n=952 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Analyses of the primary safety and effectiveness endpoints are performed on the Intent to treat (ITT) population. The ITT population is defined as subjects who meet enrollment criteria, provide signed informed consent, and who have an attempted implant of the LP. The study required a sample size of 300 evaluable subjects. The 300-subject primary analysis cohort is defined as the first 300 enrolled subjects sorted by implant date and sheath insertion time.
Complication is any device-or-procedure related serious adverse event, or serious adverse device effect, including those that prevented initial implantation. Percentage of participants free from complications are reported
Outcome measures
| Measure |
Leadless Pacemaker
n=300 Participants
Subjects who signed an approved informed consent form and had an attempted Nanostim implant, with no pre-existing implanted pacemaker at the time of consent
|
|---|---|
|
Complication-Free Rate
|
93.3 percentage of participants
Interval 89.9 to 95.9
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Analysis of the primary effectiveness endpoints was performed on subjects in the Intent to treat (ITT) population with a successful Nanostim Leadless Pacemaker implanted. This number included 289 of the 300 (96.3%) subjects in the ITT population.
Success Rate is percentage of subjects who have acceptable pacing threshold and sensing amplitudes, which are defined as pacing threshold \<=2.0V at 0.4 ms pulse width and R-wave amplitude either =\>5.0 mV at the 6 month visit or =\> value at implant.
Outcome measures
| Measure |
Leadless Pacemaker
n=289 Participants
Subjects who signed an approved informed consent form and had an attempted Nanostim implant, with no pre-existing implanted pacemaker at the time of consent
|
|---|---|
|
Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range
|
93.4 percentage of participants
Interval 89.9 to 96.0
|
SECONDARY outcome
Timeframe: 3-6 monthsPopulation: Subjects within the enrolled population with a successful implant who completed the six-minute walk test and completed at least stage 3 of the CAEP.
Temperature-based rate response feature was evaluated to determine whether an appropriate and proportional rate response was achieved during maximal effort graded treadmill exercise testing protocol (CAEP). All capable subjects who have completed the 6-minute walk test (6MWT) were asked to perform a maximal effort CAEP exercise protocol to demonstrate an appropriate and proportional response of sensor-indicated rate in graded exercise tests. Data from subjects who have completed the 6MWT and have completed at least stage 3 of the CAEP exercise protocol, or 3.6 metabolic equivalent of task (METs), were included in the analysis.
Outcome measures
| Measure |
Leadless Pacemaker
n=30 Participants
Subjects who signed an approved informed consent form and had an attempted Nanostim implant, with no pre-existing implanted pacemaker at the time of consent
|
|---|---|
|
Appropriate and Proportional Rate Response During Graded Exercise Testing
|
0.83 1/(minutes*metabolic equivalent task)
Interval 0.73 to 0.93
|
Adverse Events
Leadless Pacemaker
Serious events: 436 serious events
Other events: 236 other events
Deaths: 276 deaths
Serious adverse events
| Measure |
Leadless Pacemaker
n=952 participants at risk
Subjects who signed an approved informed consent form and had an attempted Nanostim implant, with no pre-existing implanted pacemaker at the time of consent
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Disease
|
1.3%
12/952 • Number of events 12 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Premature Battery Depletion
|
18.5%
176/952 • Number of events 180 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Pneumonia
|
1.1%
10/952 • Number of events 10 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Dizziness
|
0.53%
5/952 • Number of events 6 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Loss of Normal Device Function due to Component Malfunction
|
2.7%
26/952 • Number of events 26 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Hemothorax
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Vascular disorders
Peripheral Vascular Disease
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Heart Failure
|
4.5%
43/952 • Number of events 52 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Cardiac Perforation Resulting in Tamponade and Requiring Intervention
|
1.1%
10/952 • Number of events 10 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Infection, Local at Access Site, or Systemic
|
2.0%
19/952 • Number of events 22 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Vascular Access Complication: Access Site Bleeding
|
0.74%
7/952 • Number of events 7 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Myocardial Infarction
|
1.9%
18/952 • Number of events 25 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Hepatobiliary disorders
Choledocholithiasis
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Cardiac Arrhythmias
|
2.2%
21/952 • Number of events 23 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Elective Device Replacement
|
0.84%
8/952 • Number of events 8 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Angina Pectoris
|
1.2%
11/952 • Number of events 16 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Rib and Vertebra Fracture
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Decreased Level of Consciousness
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Nervous system disorders
Stroke
|
1.9%
18/952 • Number of events 18 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Accidental Injury
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Social circumstances
Fall
|
0.53%
5/952 • Number of events 5 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Dyspnea
|
1.3%
12/952 • Number of events 12 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Hematoma Formation, Including Retroperitoneal Hematoma/Hemorrahge
|
0.42%
4/952 • Number of events 4 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Bacteremia
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Sepsis
|
0.95%
9/952 • Number of events 9 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Cardiac Perforation/Pericardial Effusion not Requiring Intervention
|
0.32%
3/952 • Number of events 3 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Pericarditis
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Hypotension
|
0.42%
4/952 • Number of events 4 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Device Dislodgement
|
0.95%
9/952 • Number of events 9 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Left Leg Weakness During Implant Procedure
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Threshold Elevation Resulting in Second LP Implant
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Vascular disorders
Embolism
|
0.32%
3/952 • Number of events 3 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Cardiac Perforation Requiring Intervention
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Valve Damage
|
0.74%
7/952 • Number of events 7 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Psychiatric disorders
Change in Mental Status Post Procedure
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Intermittent Capture
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Pericardial Effusion or Rub
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Urinary Tract Infection
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Mechanical Trauma
|
0.32%
3/952 • Number of events 4 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Syncope
|
1.3%
12/952 • Number of events 16 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Terminal Heart Disease
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Cardiopulmonary Arrest
|
1.3%
12/952 • Number of events 12 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Gastrointestinal disorders
GI Bleeding
|
0.74%
7/952 • Number of events 10 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Renal and urinary disorders
Urinary Retention
|
0.32%
3/952 • Number of events 3 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Renal and urinary disorders
Acute Renal Failure
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Hernia
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Celulitis
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Fatigue
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Palpitations
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.2%
11/952 • Number of events 12 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Inability to Interrogate or Program due to Programmer or Device Malfunction
|
0.53%
5/952 • Number of events 5 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Pacemaker Syndrome
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Cardiomyopathy
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Investigations
Fever- Unknown Etiology
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Pulseless Electrical Activity
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Change in Mental Status
|
0.42%
4/952 • Number of events 4 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Peripheral Edema
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Aortic Stenosis
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Death, Unknown Cause
|
0.53%
5/952 • Number of events 5 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Threshold Elevation
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Dehydration
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Multi-System Organ Failure
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.42%
4/952 • Number of events 4 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Gastrointestinal disorders
Rectal Bleeding
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Vascular Access Complication: Pseudoaneurysm
|
0.53%
5/952 • Number of events 5 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.11%
1/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Detached Docking Button
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Colitis
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Ventricular Ectopy
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Access Site Bleeding Event
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Pre-Syncope
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Temporary Loss of Pacing and Sensing
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Surgical and medical procedures
RV Lead Dislodgement
|
0.32%
3/952 • Number of events 3 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Reduction in Lvef
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Pneumothorax
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Threshold Elevation Resulting in Retrieval of LP
|
0.53%
5/952 • Number of events 5 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Undifferentiated Shock
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Blood and lymphatic system disorders
Anemia
|
0.32%
3/952 • Number of events 3 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Pocket Hematoma (Pm)
|
0.32%
3/952 • Number of events 3 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Damage to Vessels
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Pneumonitis
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.74%
7/952 • Number of events 7 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Immune system disorders
Allergic Reaction to Vancomycin
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Pericardial Effusion
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Inadequate Fixation of The LP During Implant Resulting in Device Migration
|
0.53%
5/952 • Number of events 5 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Device Pocket Infection (Biv ICD)
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Vascular disorders
Femoral-Popliteal Bypass Graft Occlusion
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Vascular disorders
Thromboemboli
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Asystole During Implant Procedure
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Intermittent Loss of Device Telemetry
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Excessive Bleeding
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Hypertension
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Renal and urinary disorders
End Stage Renal Disease
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Vascular Access Complication: AV Fistula
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Chest Pain
|
0.42%
4/952 • Number of events 4 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Failure to Capture/Loss of Capture
|
0.32%
3/952 • Number of events 3 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Nervous system disorders
Seizure
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Vascular disorders
Leg Ischemia
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Nervous system disorders
Intracranial Hemorrhage
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Vascular disorders
Aortic Dissection
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Pyelonephritis
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Weakness
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
RV Pacing Induced Cardiomyopathy
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Abscess
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Gastrointestinal disorders
Ileus
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Renal and urinary disorders
Renal Failure
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Osteomyelitis
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Musculoskeletal and connective tissue disorders
Shoulder Dislocation
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Epistaxis
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Mechanical Trauma to His Bundle
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Contrast Induced Nephropathy
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Endocarditis of Prosthetic Valves
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Hand Swelling
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Nervous system disorders
Encephalopathy
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Nervous system disorders
Bell's Palsy
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Vertigo
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Tricuspid Valve Regurgitation
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Intermittent Complete Heart Block During Implant Procedure
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Perclose System Malfunction
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Septic Shock
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
Other adverse events
| Measure |
Leadless Pacemaker
n=952 participants at risk
Subjects who signed an approved informed consent form and had an attempted Nanostim implant, with no pre-existing implanted pacemaker at the time of consent
|
|---|---|
|
Infections and infestations
Abscess of The Neck
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Nervous system disorders
Hydrocephalus
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Gastrointestinal disorders
Rectal Bleeding
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Extra-Cardiac Pacing Stimulation
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Hypotension
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Renal and urinary disorders
Urinary Retention
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Gastrointestinal disorders
Constipation
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Blood and lymphatic system disorders
Bruising
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Renal and urinary disorders
Polyuria
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Gastrointestinal disorders
Dysphagia
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Skin and subcutaneous tissue disorders
Stasis Ulcer
|
0.11%
1/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Fall
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Anemia
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Cystitis
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Thromboemboli
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Thrombophlebitis
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Intermittent Loss of Device Telemetry
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Nervous system disorders
Ataxia
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Nervous system disorders
Essential Tremor
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Weakness
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Investigations
Elevated Troponin
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Vascular Access Complication: AV Fistula
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Contrast Extravasation at Groin Access Site
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Anesthesia Related Side Effect
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Interruption of Desired Pacemaker Function due to Electrical Interference
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Chest Discomfort
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Investigations
Elevated Inr
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Inadequate Fixation of The LP
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Dyspnea
|
1.9%
18/952 • Number of events 20 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Premature Battery Depletion
|
4.5%
43/952 • Number of events 44 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Vascular disorders
Embolism
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Vascular Access Complication: Access Site Bleeding
|
2.7%
26/952 • Number of events 26 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Reaction to Contrast
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Syncope
|
1.6%
15/952 • Number of events 15 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Pneumonia
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Threshold Elevation
|
0.95%
9/952 • Number of events 9 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Vascular disorders
Hypertension
|
0.42%
4/952 • Number of events 4 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Bronchitis
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Dizziness
|
1.1%
10/952 • Number of events 11 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Dehydration
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Pain
|
0.84%
8/952 • Number of events 9 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Chest Pain
|
0.63%
6/952 • Number of events 6 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Accidental Injury
|
0.32%
3/952 • Number of events 3 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Reaction to Sedation
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Unsuccessful LP Retrieval
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Undersensing
|
0.32%
3/952 • Number of events 3 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Cardiac Arrhythmias
|
2.1%
20/952 • Number of events 22 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Detached Docking Button
|
0.32%
3/952 • Number of events 3 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Pre-Syncope
|
0.53%
5/952 • Number of events 5 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Hematoma Formation, Including Retroperitoneal Hematoma/Hemorrahge
|
0.53%
5/952 • Number of events 5 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Angina Pectoris
|
0.74%
7/952 • Number of events 7 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Heart Failure
|
0.74%
7/952 • Number of events 7 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Blood and lymphatic system disorders
Epistaxis
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Tricuspid Valve Regurgitation
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Pacemaker Syndrome
|
0.63%
6/952 • Number of events 6 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
RV Pacing Induced Cardiomyopathy
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Vascular disorders
Thrombosis
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Coughing With RV Pacing
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Renal and urinary disorders
Renal Failure
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Exit Block
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Investigations
Hypercalcemia
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Inability to Interrogate or Program due to Programmer or Device Malfunction
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Infection, Local at Access Site, or Systemic
|
0.84%
8/952 • Number of events 8 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Loss of Normal Device Function due to Component Malfunction
|
1.4%
13/952 • Number of events 14 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Eye disorders
Temporary Loss of Vision
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Skin and subcutaneous tissue disorders
Mild Skin Reaction to Pre-Procedural Prep
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Open Wound
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Hand Injury
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Nickel Allergy
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Myocardial Infarction
|
0.11%
1/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Mechanical Trauma
|
0.21%
2/952 • Number of events 5 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Cardiac Perforation/Pericardial Effusion not Requiring Intervention
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Valve Damage
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Inability to Release Snare from Docking Button
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
High Impedance
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Musculoskeletal and connective tissue disorders
Myalgias
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Nervous system disorders
Left Sided Numbness
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Helix Distortion
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Migraines
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Failure to Capture/Loss of Capture
|
0.53%
5/952 • Number of events 5 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Palpitations
|
0.32%
3/952 • Number of events 3 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Vascular Access Complication: Access Site Lymphatic Drainage
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Pericardial Effusion
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Access Site Bleeding Event
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Fatigue
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Psychiatric disorders
Memory Loss
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Uvulitis After Implant Procedure
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Tricuspid Regurgitation
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Pleural Effusions
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Spine Fracture
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Vascular disorders
Aortic Aneurysm
|
0.21%
2/952 • Number of events 2 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Asystole During Implant Procedure
|
0.11%
1/952 • Number of events 1 • Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
Additional Information
Nicole Harbert, Director Clinical Research
Abbott Cardiac Rhythm Management
Phone: 972-526-4841
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place