Trial Outcomes & Findings for Aveir DR i2i Study (NCT NCT05252702)

NCT ID: NCT05252702

Last Updated: 2025-08-15

Results Overview

Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects. A complication was defined as a device-or-procedure-related serious adverse event. Complications included Atrial LP, Ventricular LP, and implant procedure-related complications. Complications possibly related or related to COVID-19 were excluded.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 464 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2025-08-15

Participant Flow

Subject enrollment in the Aveir DR i2i IDE study began on February 2, 2022 in Czech Republic, February 24, 2022 in the US, April 7, 2022 in Canada, October 14, 2022 in Hong Kong, and February 9, 2023 in Taiwan. The study enrolled 464 de novo subjects at 77 sites worldwide

Participant milestones

Measure	Enrolled de Novo Cohort The enrolled de novo cohort consisted of subjects that were screened for and met eligibility criteria, provided written informed consent, and were scheduled to undergo a dual chamber Aveir DR leadless pacemaker system implant wherein a leadless pacemaker was to be implanted in the right ventricle and right atrium
Overall Study STARTED	464
Overall Study Attempted Implant	452
Overall Study Predischarge Visit	450
Overall Study 1-month Visit	443
Overall Study 3-month Visit	442
Overall Study 6-month Visit	435
Overall Study 12-month Visit	360
Overall Study 18-month Visit	100
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	434

Reasons for withdrawal

Measure	Enrolled de Novo Cohort The enrolled de novo cohort consisted of subjects that were screened for and met eligibility criteria, provided written informed consent, and were scheduled to undergo a dual chamber Aveir DR leadless pacemaker system implant wherein a leadless pacemaker was to be implanted in the right ventricle and right atrium
Overall Study No attempted implant, subjects withdrawn	12
Overall Study Death	16
Overall Study System explant	5
Overall Study Lost to Follow-up	1
Overall Study Withdrawn by investigator	1
Overall Study Visit not due	306
Overall Study Visit within window but not completed	92
Overall Study Unsuccessful implant	1

Baseline Characteristics

Aveir DR i2i Study

Baseline characteristics by cohort

Measure	Enrolled de Novo Cohort With Attempted Implant n=452 Participants The enrolled de novo cohort with attempted implant group consisted of subjects that were screened for and met eligibility criteria, provided written informed consent, and had an attempted dual chamber Aveir DR leadless pacemaker system implant
Age, Continuous	69.8 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	174 Participants n=5 Participants
Sex: Female, Male Male	278 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants n=5 Participants
Race/Ethnicity, Customized Asian	46 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	13 participants n=5 Participants
Race/Ethnicity, Customized White	282 participants n=5 Participants
Race/Ethnicity, Customized Declined/Unable to Disclose	100 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	6 Participants n=5 Participants
Race/Ethnicity, Customized Multi-Racial	1 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	15 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	331 Participants n=5 Participants
Region of Enrollment Hong Kong	11 Participants n=5 Participants
Region of Enrollment United States	280 Participants n=5 Participants
Region of Enrollment Czechia	33 Participants n=5 Participants
Region of Enrollment Japan	24 Participants n=5 Participants
Region of Enrollment United Kingdom	8 Participants n=5 Participants
Region of Enrollment Spain	18 Participants n=5 Participants
Region of Enrollment Canada	33 Participants n=5 Participants
Region of Enrollment Austria	5 Participants n=5 Participants
Region of Enrollment Netherlands	4 Participants n=5 Participants
Region of Enrollment Belgium	6 Participants n=5 Participants
Region of Enrollment Taiwan	5 Participants n=5 Participants
Region of Enrollment Italy	7 Participants n=5 Participants
Region of Enrollment France	18 Participants n=5 Participants
Height	170.7 cm STANDARD_DEVIATION 10.8 • n=5 Participants
Weight	81.6 kg STANDARD_DEVIATION 19.8 • n=5 Participants
BMI	27.8 kg/m^2 STANDARD_DEVIATION 5.7 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: The primary analysis population for the primary safety endpoint was based on subjects in the full analysis population. The full analysis population included the first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant. A de novo subject was a subject who did not have an implanted pacemaker on the date of consent through the date of the attempted Aveir LP implant

Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects. A complication was defined as a device-or-procedure-related serious adverse event. Complications included Atrial LP, Ventricular LP, and implant procedure-related complications. Complications possibly related or related to COVID-19 were excluded.

Outcome measures

Measure	Primary Analysis Population n=300 Participants The first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant.
Percentage of Participants Free From Aveir DR System-Related Complications at 3-months	90.3 percentage of participants Interval 87.0 to 93.7

PRIMARY outcome

Timeframe: 12 months

Population: The primary analysis population for the primary safety endpoint was based on subjects in the full analysis population. The full analysis population included the first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant. A de novo subject was a subject who did not have an implanted pacemaker on the date of consent through the date of the attempted Aveir LP implant.

Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects. A complication was defined as a device-or-procedure-related serious adverse event. Complications included Atrial LP, Ventricular LP, and implant procedure-related complications. Complications possibly related or related to COVID-19 were excluded.

Outcome measures

Measure	Primary Analysis Population n=300 Participants The first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant.
Percentage of Participants Free From Aveir DR System-Related Complications at 12-months	88.6 percentage of participants Interval 84.5 to 91.8

PRIMARY outcome

Timeframe: 3 months

Population: Among the 300 subjects in the full analysis population, 3 subjects were excluded due to unsuccessful atrial device implant and unmeasurable p-wave amplitude.

Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects. A subject was considered to have met the primary effectiveness endpoint #1 if the pacing threshold voltage was ≤ 3.0 V at 0.4 ms at the 3-month visit and the sensed P-wave amplitude was ≥ 1.0 mV at the 3-month visit.

Outcome measures

Measure	Primary Analysis Population n=297 Participants The first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant.
Percentage of Subjects With Acceptable Atrial Threshold and Amplitude Measurements at 3-months	90.8 percentage of participants Interval 87.5 to 94.1

PRIMARY outcome

Timeframe: 12 months

Population: Out of 300 subjects, 8 subjects were excluded from primary effectiveness endpoint. 2 were excluded for unsuccessful atrial device implant and 6 were excluded due to unmeasurable P-wave amplitudes and pacing voltages at the 12-month visit due to atrial fibrillation/ atrial tachycardia.

Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects. A subject was considered to have met the success criteria for the endpoint if the pacing threshold voltage was ≤ 3.0 V at 0.4 ms at the 12-month visit and the sensed P-wave amplitude was ≥ 1.0 mV at the 12-month visit.

Outcome measures

Measure	Primary Analysis Population n=292 Participants The first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant.
Percentage of Subjects With Acceptable Atrial Threshold and Amplitude Measurements at 12-months	92.8 percentage of participants Interval 89.7 to 95.8

PRIMARY outcome

Timeframe: 3 months

Population: Out of 300 subjects in the full analysis population, 2 were excluded due to unsuccessful atrial implants. Then out of 298 subjects, 277 subjects with AV Synchrony data available to define endpoint success were included.

AV synchrony success was defined as subjects with a paced or sensed ventricular beat within 300 ms following a paced or sensed atrial beat (i.e., a synchronous cycle) for at least 70% of evaluable cardiac cycles.

Outcome measures

Measure	Primary Analysis Population n=277 Participants The first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant.
Percentage of Participants With AV Synchrony Success Rate at Rest While Seated	98.2 percentage of participants Interval 96.6 to 99.8

SECONDARY outcome

Timeframe: 3 months

Population: The primary analysis population for the secondary safety endpoint was based on subjects in the full analysis population, which included the first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant.

The secondary safety endpoint evaluated a 3-month Atrial LP related complication-free rate based on CEC adjudication of adverse events. An Atrial LP complication was defined as an atrial device-or-procedure-related serious adverse event. Complications that were exclusively related to the Ventricular LP or its delivery/retrieval were not considered Atrial LP complications and were excluded from the evaluation. For a conservative approach, complications that could not exclusively be determined to be related to the ventricular or Atrial LP were still considered Atrial LP complications. For example, procedure-related femoral access complications were adjudicated as Atrial LP complications.

Outcome measures

Measure	Primary Analysis Population n=300 Participants The first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant.
Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 3-months	91.3 percentage of participants Interval 88.1 to 94.5

SECONDARY outcome

Timeframe: 12 months

Population: The analysis population for the secondary safety endpoint was based on subjects in the full analysis population, which included the first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant.

The secondary safety endpoint analysis evaluated the 12-month Atrial LP related complication-free rate (CFRA) based on CEC adjudication of adverse events. An Atrial LP complication was defined as an atrial device-or-procedure-related serious adverse event. Complications that were exclusively related to the Ventricular LP or its delivery/retrieval were not considered Atrial LP complications and were excluded from the evaluation. For a conservative approach, complications that could not exclusively be determined to be related to the ventricular or Atrial LP were still considered Atrial LP complications. For example, procedure-related femoral access complications were adjudicated as Atrial LP complications. Complications possibly related or related to COVID-19 were excluded.

Outcome measures

Measure	Primary Analysis Population n=300 Participants The first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant.
Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 12-months	91.0 percentage of participants Interval 87.1 to 93.7

SECONDARY outcome

Timeframe: 3 months

Population: Subjects with Analyzable CAEP Data

Appropriate and proportional rate response of the Aveir Atrial Leadless Pacemaker in de novo subjects was tested during staged exercise testing. Exercise test data provided an estimate of the slope of the normalized increase in sensor-indicated rate versus normalized workload for each subject. Normalizing a variable eliminates the unit and expresses it from 0-1.0. Since both axes are normalized sensor rate and workload, there is no distinct unit of measure. Values on the vertical axis are derived from the difference of the sensor indicated rate at each exercise stage and the base rate, divided by the difference of the age-predicted maximum heart rate and base rate. Values on the horizontal axis are derived from the difference in the workload at each exercise stage and resting workload, divided by the difference of the maximum achieved workload and resting workload. A slope value of 1.0 indicates the pacemaker's sensor-indicated rate increases linearly with an increase in workload.

Outcome measures

Measure	Primary Analysis Population n=20 Participants The first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant.
Slope of the Normalized Increase in the Sensor Indicated Rate Versus Normalized Workload of the Aveir Atrial Leadless Pacemaker During Exercise Testing	0.91 unitless Interval 0.78 to 1.04

Adverse Events

Enrolled de Novo Cohort With Attempted Implant

Serious events: 202 serious events

Other events: 366 other events

Deaths: 16 deaths

Serious adverse events

Measure	Enrolled de Novo Cohort With Attempted Implant n=452 participants at risk The enrolled de novo cohort with attempted implant group consisted of subjects that were screened for and met eligibility criteria, provided written informed consent, and had an attempted dual chamber Aveir DR leadless pacemaker system implant
Cardiac disorders Cardiac Arrhythmia - Atrial Fibrillation	9.1% 41/452 • Number of events 44 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Heart Failure	4.0% 18/452 • Number of events 22 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Cardiac Arrhythmia - Supraventricular Arrhythmia	2.4% 11/452 • Number of events 14 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Infections and infestations Infection, Local at Access Site, or Systemic	2.2% 10/452 • Number of events 12 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Syncope	0.66% 3/452 • Number of events 7 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Accidental Injury/Mechanical Trauma	1.3% 6/452 • Number of events 6 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Musculoskeletal and connective tissue disorders Pain	1.5% 7/452 • Number of events 7 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Respiratory, thoracic and mediastinal disorders Respiratory Failure/Respiratory Insufficiency	1.3% 6/452 • Number of events 6 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Investigations Electrolyte Disbalance	0.66% 3/452 • Number of events 5 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Renal and urinary disorders Urinary Tract Infection/UTI	0.88% 4/452 • Number of events 5 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Chest Pain - Non-Cardiac	1.1% 5/452 • Number of events 5 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Death	1.1% 5/452 • Number of events 5 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Infections and infestations Sepsis	1.1% 5/452 • Number of events 5 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Nervous system disorders Stroke	1.1% 5/452 • Number of events 5 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Infections and infestations Covid-19 Infection	1.1% 5/452 • Number of events 5 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Hypotension	0.88% 4/452 • Number of events 4 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Tumor/Malignant Disease	0.88% 4/452 • Number of events 4 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Myocardial Infarction	0.88% 4/452 • Number of events 4 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Renal and urinary disorders Renal Failure/Insufficiency	0.88% 4/452 • Number of events 4 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Gastrointestinal disorders Abdominal Pain	0.44% 2/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Vascular disorders Peripheral Artery Disease	0.44% 2/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Dyspnea	0.66% 3/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Transient Ischemic Attack	0.66% 3/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Valve Disease	0.66% 3/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Pericarditis	0.22% 1/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Anemia	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Angina Pectoris	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Cardiac Perforation	0.66% 3/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Coronary Artery Disease	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Endocrine disorders Diabetes	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Gastrointestinal disorders Gastrointestinal Bleeding/Hemorrhage	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Musculoskeletal and connective tissue disorders Hernia	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Hypertension	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Hypoglycemia	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.66% 3/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Infections and infestations Pneumonia	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Pre-Syncope	0.66% 3/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Thrombosis	0.66% 3/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Weakness	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Cardiac Arrhythmia - Ventricular Arrhythmia	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Cardiomyopathy	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Gastrointestinal disorders Constipation	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Dizziness	1.3% 6/452 • Number of events 6 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Nervous system disorders Encephalopathy	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Excessive Bleeding	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Hepatobiliary disorders Gallbladder Disease	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Gastrointestinal disorders Gastroenteritis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Hematoma Formation, Including Retroperitoneal Hematoma/Hemorrhage	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Respiratory, thoracic and mediastinal disorders Pneumothorax/Hemothorax	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Reaction/Toxic Effect Due to Contrast Media	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Fall	1.3% 6/452 • Number of events 6 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Hepatobiliary disorders Cholecystitis	0.88% 4/452 • Number of events 4 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Psychiatric disorders Altered Mental Status	0.66% 3/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Cardiac Arrest	0.66% 3/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Femur Fracture	0.66% 3/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Fluid Overload	0.66% 3/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Nervous system disorders Parkinson's Disease	0.66% 3/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Mechanical Device Dislodgement	0.66% 3/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Pulmonary Hypertension	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Infections and infestations Shock	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Acute Coronary Syndrome	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Infections and infestations Acute Hepatitis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Psychiatric disorders Acute Psychosis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Psychiatric disorders Adjustment Disorder	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Endocrine disorders Adrenal insufficiency	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Anal Nodule	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Av Fistula Malfunction	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Calciphylaxis of Penis Fistula	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Carotid Artery Stenosis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Eye disorders Cataract	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Vascular disorders Cerebrovascular Accident	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Chest Pain Unspecified	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Chronic Right Elbow Olecranon Bursitis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Musculoskeletal and connective tissue disorders Coxarthrosis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Hepatobiliary disorders Cystitis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Hepatobiliary disorders Diarrhea	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Reproductive system and breast disorders Enlarged Prostate	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Gastrointestinal disorders Gastroesophageal Reflux	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Generalized Weakness	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Musculoskeletal and connective tissue disorders Gonarthrosis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Head Laceration	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Investigations Hyponatremia	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Gastrointestinal disorders Ileitis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Gastrointestinal disorders Ileus	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Musculoskeletal and connective tissue disorders Knee Arthrosis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Left Atrial Appendage Occlusion	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Leg Weakness	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Low Ejection Fraction	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Musculoskeletal and connective tissue disorders Lumbar Pain	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Musculoskeletal and connective tissue disorders Lumbar Spinal Stenosis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Renal and urinary disorders Nephrolithiasis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parotid Tumor	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Eye disorders Pseudophakia	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Musculoskeletal and connective tissue disorders Sacroiliac Join Dysfunction	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Gastrointestinal disorders Small Bowel Obstruction	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Stent Restenosis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Psychiatric disorders Suicidal Ideations	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid Nodule	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Musculoskeletal and connective tissue disorders Vertebrae Fracture	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Vertigo	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Eye disorders Vision Loss	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Vomiting	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Threshold Elevation	1.5% 7/452 • Number of events 7 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Inadequate Fixation During Implant with LP Migration	1.1% 5/452 • Number of events 5 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Renal and urinary disorders Urinary Retention	1.1% 5/452 • Number of events 5 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Inadequate Fixation During Implant Without LP Migration	0.66% 3/452 • Number of events 4 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Pericardial Effusion or Rub	0.88% 4/452 • Number of events 4 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Access Site Bleeding	0.66% 3/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Intermittent Capture	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Tricuspid Valve Damage And/or Regurgitation	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Pacemaker Syndrome	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Palpitations	2.0% 9/452 • Number of events 10 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Intermittent or Loss of I2i Communication	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Oversensing	0.66% 3/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Vascular disorders Arteriovenous Fistula	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Pleural Effusion	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Pulmonary Embolism	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Cardiac Tamponade	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Inability to Release and Redock the LP	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications False Magnet Mode	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Cardiopulmonary Arrest	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Access site Oozing	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Arterial Laceration	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Infections and infestations Cardiogenic Shock	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Complete Heart Block	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Device Dislogdement	2.7% 12/452 • Number of events 14 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Complete AV Block	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.

Other adverse events

Measure	Enrolled de Novo Cohort With Attempted Implant n=452 participants at risk The enrolled de novo cohort with attempted implant group consisted of subjects that were screened for and met eligibility criteria, provided written informed consent, and had an attempted dual chamber Aveir DR leadless pacemaker system implant
Musculoskeletal and connective tissue disorders Pain	7.5% 34/452 • Number of events 41 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Cardiac Arrhythmia - Atrial Fibrillation	8.2% 37/452 • Number of events 40 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Palpitations	7.5% 34/452 • Number of events 36 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Infections and infestations Covid-19 Infections	6.0% 27/452 • Number of events 27 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Dizziness	6.4% 29/452 • Number of events 30 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Infections and infestations Infection, Local at Access Site, or Systemic	4.6% 21/452 • Number of events 25 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Renal and urinary disorders Urinary Tract Infection/UTI	2.9% 13/452 • Number of events 16 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Chest Pain - Non-Cardiac	3.8% 17/452 • Number of events 19 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Dyspnea	5.5% 25/452 • Number of events 25 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Accidental Injury/Mechanical Trauma	2.7% 12/452 • Number of events 14 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Hypotension	2.4% 11/452 • Number of events 13 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Heart Failure	2.7% 12/452 • Number of events 15 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Cardiac Arrhythmia - Supraventricular Arrhythmia	2.7% 12/452 • Number of events 13 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Syncope	1.5% 7/452 • Number of events 8 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Hypertension	1.8% 8/452 • Number of events 8 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Abdominal Pain	1.3% 6/452 • Number of events 7 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Anemia	1.5% 7/452 • Number of events 7 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Renal and urinary disorders Renal Failure/Insufficiency	1.5% 7/452 • Number of events 7 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Angina Pectoris	1.1% 5/452 • Number of events 5 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Cardiac Arrhythmia - Ventricular Arrhythmia	1.3% 6/452 • Number of events 6 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Investigations Electrolyte Disbalance	1.1% 5/452 • Number of events 5 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Weakness	1.8% 8/452 • Number of events 8 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Gastrointestinal disorders Constipation	0.66% 3/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Nausea	0.66% 3/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Pleural Effusion	0.66% 3/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Investigations Dehydration	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Musculoskeletal and connective tissue disorders Hernia	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Pulmonary Edema	0.88% 4/452 • Number of events 4 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Renal and urinary disorders Urinary Retention	0.66% 3/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Valve Disease	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Access Site Bleeding Event	5.1% 23/452 • Number of events 23 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Aortic Aneurysm	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Cardiomyopathy	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Coronary Artery Disease	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Endocrine disorders Diabetes	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Gastrointestinal disorders Gastrointestinal Bleeding/Hemorrhage	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Reproductive system and breast disorders Groin Pain	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Hypoglycemia	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Musculoskeletal and connective tissue disorders Myalgia	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Oversensing	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Pericardial Effusion or Rub	1.1% 5/452 • Number of events 5 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Peripheral Artery Disease	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Pre-Syncope	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Thrombosis	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Transient Ischemic Attack	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Fall	2.2% 10/452 • Number of events 10 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Psychiatric disorders Anxiety	0.66% 3/452 • Number of events 5 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Diarrhea	1.1% 5/452 • Number of events 5 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Headache	0.88% 4/452 • Number of events 4 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Renal and urinary disorders Hematuria	0.88% 4/452 • Number of events 4 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Lower Extremity Edema	1.1% 5/452 • Number of events 5 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Fatigue	1.1% 5/452 • Number of events 5 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Renal and urinary disorders Acute Kidney Injury	0.88% 4/452 • Number of events 4 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Asthenia	0.66% 3/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Psychiatric disorders Depression	0.66% 3/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Shortness of Breath	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Musculoskeletal and connective tissue disorders Chest Pain - Unspecified	0.88% 4/452 • Number of events 4 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Cough	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Nervous system disorders Dementia	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Elevated D-Dimer	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Infections and infestations Fever	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Infections and infestations Infection	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Skin and subcutaneous tissue disorders Skin Lesions	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Skin and subcutaneous tissue disorders Skin Rash	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Endocrine disorders Thyroid Leves Abnormal	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Psychiatric disorders Adjustment Disorder	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Allergic Reaction	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Psychiatric disorders Altered Mental State	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Musculoskeletal and connective tissue disorders Arthritis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Skin and subcutaneous tissue disorders Asteatosis Eczema	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Respiratory, thoracic and mediastinal disorders Asthmatic Bronchitis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Gastrointestinal disorders Barrett's Esophagus	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Musculoskeletal and connective tissue disorders Bilateral Upper Limb Numbness	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Eye disorders Blurred Vision	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Bruise	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Cardiomegaly	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Musculoskeletal and connective tissue disorders Carpal Tunnel Syndrome	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Skin and subcutaneous tissue disorders Cellulitis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Chest Discomfort	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Chest Pain Unspecified	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Chest Pressure	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Chest TIghtness	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Musculoskeletal and connective tissue disorders Chronic Dislocated Right Shoulder	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Hepatobiliary disorders Cirrhotic Liver	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Coccyx Fracture	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Confusion	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Deep Vein Thrombosis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Eye disorders Deterioration of Vision	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Nervous system disorders Drug-Induced Parkinsonism	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Nervous system disorders Dysautonomia	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Gastrointestinal disorders Dyspepsia	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Nervous system disorders Dysphagia	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Reproductive system and breast disorders Erectile Dysfunction	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Respiratory, thoracic and mediastinal disorders Exacerbation of Asthma	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Eye disorders Eye Floaters	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Eye disorders Eye Irritation	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Fistula Discharge	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Fluid Overload	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Frontoparietal Meningioma	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Gastrointestinal disorders Gastroesophageal Reflux	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Hallucination	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Heartburn	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Hepatobiliary disorders Hepatic Lesion	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Hot Flashes	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Humerus Fracture	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Investigations Hyponatremia	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Endocrine disorders Hypothyroidism	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Skin and subcutaneous tissue disorders Ingrown Toenail	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Insomnia	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Left Arm Fracture	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Left Hand Numbness	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Leg Weakness	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Low Hemoglobin	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Nodules	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Malaise	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nodules Right Thyroid Gland	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Numbness/Tingling in Lower	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Infections and infestations Ophthalmic Herpes Zoster	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Infections and infestations Oral Ulcers	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Orthostatic Hypotension	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Pacemaker Mediated Tachycardia	1.1% 5/452 • Number of events 5 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Pain	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Infections and infestations Pansinusitis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Paresthesia	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Patent Foramen Ovale	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Periodontal Disease	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Polyp	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Infections and infestations Post-Operative Wound Infection	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Pressure in the Head	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Pressure Ulcer	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Pruritus	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pulmonary Nodules	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Qt Prolongation	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Rapid Heart Rate	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Polyp	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Restless Leg Syndrome	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Rib Fracture	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Right Second Toe Blister	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Nervous system disorders Sciatica	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Seizure	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Skin and subcutaneous tissue disorders Skin Cyst	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Skin and subcutaneous tissue disorders Stasis Dermatitis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Sublingual Bleeding	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Tachycardia	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Thrombocytopenia	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Thrombophlebitis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroglossal Duct Cyst	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Infections and infestations Tinea Cruris	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Tongue Laceration	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Tympan Perforation	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Hepatobiliary disorders Ulcerative Colitis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Gastrointestinal disorders Unsteady Gait	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Renal and urinary disorders Urinary Hesitancy	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Skin and subcutaneous tissue disorders Urticaria	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Varicose Veins	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Vein Stenosis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Venous Disease	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Venous Reflux	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Eye disorders Vision Loss	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Vomiting	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Wrist Sprain	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Threshold Elevation	4.9% 22/452 • Number of events 23 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Intermitted or Loss of I2i Communication	3.5% 16/452 • Number of events 16 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Hematoma Formation, Including Retroperitoneal Hematoma/Hemorrhage	3.1% 14/452 • Number of events 14 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Inability to Interrogate or Program due to Programmer or LP Malfunction	2.0% 9/452 • Number of events 11 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Nervous system disorders Phrenic Nerve/Diaphragmatic/Extra-Cardiac Stimulation	0.66% 3/452 • Number of events 4 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Intermittent Capture	0.44% 2/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Pacemaker Syndrome	0.66% 3/452 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Failure to Capture/Loss of Capture	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Tricuspid Valve Damage and/or Regurgitation	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Interruption of Desired LP Function due to Electrical Interference, Electromyogenic or Electromagnet	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Undersensing	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications False Magnet Mode	1.5% 7/452 • Number of events 7 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Intermittent or Loss of Sensing	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Access Site Induration	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Access Site Oozing	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Vascular disorders Vascular Dissection	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Inability to Release and Redock the LP	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Non-Healing Wound	0.44% 2/452 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications Inability to Interrogate Device Due to Interference from Swan Ganz Continuous Cardiac Output Monitor	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Left Ventricular Dysfunction	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Injury, poisoning and procedural complications LP Found in Rom Mode	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Infections and infestations Access Site Infection	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Epistaxis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Blood and lymphatic system disorders Leukocytosis	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Vascular disorders Radial Artery Occlusion	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
General disorders Visual Hallucinations	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.
Cardiac disorders Right Bundle Branch Block	0.22% 1/452 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 24 months Adverse event data includes both device and non-device related events.

Additional Information

Nicole Harbert, Director of Clinical Research

Abbott Medical Devices, Cardiac Rhythm Management

Phone: 972-526-4841

Email: nicole.harbert@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place