Trial Outcomes & Findings for ImageReady(TM) MR Conditional Pacing System Clinical Study (NCT NCT01781078)

NCT ID: NCT01781078

Last Updated: 2019-12-03

Results Overview

The primary safety endpoint for SAMURAI will be assessed for all subjects randomized to the MRI Group who undergo any portion of the MRI scan sequences. Safety will be confirmed by evaluating the MRI scan-related Complication-free rate (CFR) between the MR Scan and the MRI Visit + 1 Month Visit.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 363 participants
• Primary outcome timeframe: MRI Visit + 1 Month
• Results posted on: 2019-12-03

Participant Flow

363 patients were consented and enrolled in this study. 11 patients were withdrawn pre-implantation. 352 patients underwent the implantation procedure and 348 patients were successfully implanted. 1 patient died prior to randomization.

Participant milestones

Measure	MRI Group Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant. MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment ImageReady System implant: Pacemaker and lead(s) implant	Control Group Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups. ImageReady System implant: Pacemaker and lead(s) implant	Patients Withdrawn Prior to Randomization Patients who consented to the study but were withdrawn prior to the randomization.
Overall Study STARTED	229	118	16
Overall Study COMPLETED	217	113	0
Overall Study NOT COMPLETED	12	5	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ImageReady(TM) MR Conditional Pacing System Clinical Study

Baseline characteristics by cohort

Measure	MRI Group n=229 Participants Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant. MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment ImageReady System implant: Pacemaker and lead(s) implant	Control Group n=118 Participants Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups. ImageReady System implant: Pacemaker and lead(s) implant	Total n=347 Participants Total of all reporting groups
Age, Continuous	69.0 years STANDARD_DEVIATION 13.0 • n=5 Participants	70.4 years STANDARD_DEVIATION 11.9 • n=7 Participants	69.4 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	102 Participants n=5 Participants	63 Participants n=7 Participants	165 Participants n=5 Participants
Sex: Female, Male Male	127 Participants n=5 Participants	55 Participants n=7 Participants	182 Participants n=5 Participants
Region of Enrollment Canada	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Singapore	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	162 Participants n=5 Participants	83 Participants n=7 Participants	245 Participants n=5 Participants
Region of Enrollment China	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Malaysia	21 Participants n=5 Participants	8 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment Israel	21 Participants n=5 Participants	13 Participants n=7 Participants	34 Participants n=5 Participants
Region of Enrollment Australia	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: MRI Visit + 1 Month

Population: The primary safety endpoint for SAMURAI will be assessed for all subjects randomized to the MRI Group who underwent any portion of the MRI scan sequences and did not have a medically necessary scan performed prior to the MRI visit + 1 month follow-up.

The primary safety endpoint for SAMURAI will be assessed for all subjects randomized to the MRI Group who undergo any portion of the MRI scan sequences. Safety will be confirmed by evaluating the MRI scan-related Complication-free rate (CFR) between the MR Scan and the MRI Visit + 1 Month Visit.

Outcome measures

Measure	MRI Group n=180 Participants Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant. MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment ImageReady System implant: Pacemaker and lead(s) implant	Control Group Those subjects randomized to the Control Group will not undergo study-specific MRI scan. All follow-up time requirements are the same for the two groups. ImageReady System implant: Pacemaker and lead(s) implant
Proportion of Participants Without MR Scan-related Complications	100 Percentage of participants Interval 100.0 to 100.0	—

PRIMARY outcome

Timeframe: MRI + 1 Month Visit

Population: For the per-protocol analysis, a total of 96 Control Group subjects and 167 MRI Group subjects had paired threshold measurements and met the inclusion criteria.

The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to RF field-induced heating, which in turn may cause elevated pacing thresholds. Primary Effectiveness Endpoint 1 will evaluate any chronic effects from lead heating that will be seen through increased pacing threshold at the MRI Visit + 1 Month follow-up.

Subjects with an increase in pacing thresholds s 0.5V (at 0.5 ms) from pre-MR Scan/Control Group visit to MRI/Control visit + 1 Month follow-up were considered a success. A success rate was calculated for both the MRI and the Control Groups.

Outcome measures

Measure	MRI Group n=167 Participants Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant. MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment ImageReady System implant: Pacemaker and lead(s) implant	Control Group n=96 Participants Those subjects randomized to the Control Group will not undergo study-specific MRI scan. All follow-up time requirements are the same for the two groups. ImageReady System implant: Pacemaker and lead(s) implant
Success Rate for Threshold Measurement at 1 Month Post-MRI Scan or Control Group Visit	98.2 % of participants with success	97.9 % of participants with success

PRIMARY outcome

Timeframe: MRI + 1 Month Visit

Population: Right Atrium: a total of 78 Control Group subjects and 135 MRI Group subjects had paired sensed amplitude measurements and met the inclusion criteria. Right Ventricle: a total of 91 Control Group subjects and 152 MRI Group subjects had paired sensed amplitude measurements and met the inclusion criteria.

The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to Radiofrequency (RF) field-induced heating. Primary Effectiveness Endpoint 2 will evaluate any chronic effects from lead heating that will be seen through decreased sensed amplitude at the MRI Visit + 1 Month follow-up. Data were analyzed separately by chamber, Right Atrium (RA) and Right Ventricle (RV), for this endpoint.

Outcome measures

Measure	MRI Group n=169 Participants Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant. MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment ImageReady System implant: Pacemaker and lead(s) implant	Control Group n=287 Participants Those subjects randomized to the Control Group will not undergo study-specific MRI scan. All follow-up time requirements are the same for the two groups. ImageReady System implant: Pacemaker and lead(s) implant
Success Rate for Sensed Amplitude Measurement at 1 Month Post-MRI Scan or Control Group Visit Right Atrium (RA)	96.2 % of participants with success	96.3 % of participants with success
Success Rate for Sensed Amplitude Measurement at 1 Month Post-MRI Scan or Control Group Visit Right Ventricle (RV)	96.7 % of participants with success	96.7 % of participants with success

SECONDARY outcome

Timeframe: 3 months post implant

Overall safety of the ImageReady System will be confirmed by evaluating system-related complications that occur from system implant through 3 months post implant for all subjects who underwent an implant procedure and and reached 91 days of follow-up.

Outcome measures

Measure	MRI Group n=326 Participants Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant. MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment ImageReady System implant: Pacemaker and lead(s) implant	Control Group Those subjects randomized to the Control Group will not undergo study-specific MRI scan. All follow-up time requirements are the same for the two groups. ImageReady System implant: Pacemaker and lead(s) implant
Proportion of Participants Without ImageReady System-related Complications	94.5 Percentage of participants Interval 91.9 to 94.5	—

Adverse Events

MRI Group

Serious events: 123 serious events

Other events: 163 other events

Deaths: 0 deaths

Control Group

Serious events: 67 serious events

Other events: 82 other events

Deaths: 0 deaths

Serious adverse events

Measure	MRI Group n=229 participants at risk Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant. MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment ImageReady System implant: Pacemaker and lead(s) implant	Control Group n=118 participants at risk Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups. ImageReady System implant: Pacemaker and lead(s) implant
Product Issues Early ERI - Random component failure	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Erosion	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Infection (> 30 days post-implant)	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Impedance > 2000 ohms - RA	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Dislodgment - RA	1.3% 3/229 • Number of events 3 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	1.7% 2/118 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Other - RA Lead	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Elevated threshold - RV	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Myocardial perforation post-implant - RV	1.3% 3/229 • Number of events 3 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Impedance > 2000 ohms - RV	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Dislodgment - RV	0.87% 2/229 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Surgical and medical procedures Post-surgical infection (<= 30 days post-implant)	0.00% 0/229 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	1.7% 2/118 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Surgical and medical procedures Adverse reaction - General	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Surgical and medical procedures Physical trauma	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Surgical and medical procedures Myocardial perforation without tamponade	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Surgical and medical procedures Myocardial perforation with tamponade	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Surgical and medical procedures Venous occlusion	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Dyspnea - Heart failure	2.2% 5/229 • Number of events 6 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Pulmonary edema - Heart failure	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Fatigue - Heart failure	0.00% 0/229 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Heart failure symptoms - Unspecified	3.1% 7/229 • Number of events 7 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	3.4% 4/118 • Number of events 5 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Multiple heart failure symptoms	3.5% 8/229 • Number of events 9 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	4.2% 5/118 • Number of events 5 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Hypertension - Heart failure	0.00% 0/229 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Other - Heart failure patient condition	1.3% 3/229 • Number of events 3 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	2.5% 3/118 • Number of events 3 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders 3rd degree AV block	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Ventricular fibrillation (VF)	0.87% 2/229 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Ventricular tachycardia (VT)	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Torsades des pointes	0.00% 0/229 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Nonsustained ventricular tachycardia (NSVT)	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	1.7% 2/118 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Atrial fibrillation (AF)	5.2% 12/229 • Number of events 21 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	7.6% 9/118 • Number of events 9 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Atrial flutter	2.2% 5/229 • Number of events 7 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	3.4% 4/118 • Number of events 5 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Other SVT (AVRT, AVNRT, EAT etc.)	0.87% 2/229 • Number of events 3 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	2.5% 3/118 • Number of events 3 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Hypotension	1.7% 4/229 • Number of events 4 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Hypertension	0.87% 2/229 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Cardiac arrest	0.87% 2/229 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Myocardial infarction	2.2% 5/229 • Number of events 5 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Peripheral vascular disease	0.87% 2/229 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Aortic stenosis	1.7% 4/229 • Number of events 5 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Mitral regurgitation	0.00% 0/229 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Syncope	2.2% 5/229 • Number of events 5 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	1.7% 2/118 • Number of events 4 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Dizziness	1.3% 3/229 • Number of events 3 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	1.7% 2/118 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Chest pain - Ischemic	2.6% 6/229 • Number of events 6 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Chest pain - Other	5.2% 12/229 • Number of events 14 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	1.7% 2/118 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Dyspnea	2.2% 5/229 • Number of events 5 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Palpitations	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Multiple symptoms	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Transient ischemic attack (TIA)	0.87% 2/229 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Cerebrovascular accident (CVA)	1.7% 4/229 • Number of events 4 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	3.4% 4/118 • Number of events 4 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Deep vein thrombosis (DVT)	1.3% 3/229 • Number of events 3 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Pulmonary embolism (PE)	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Intracardiac thrombus	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Hemorrhage	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Other - Patient condition	1.7% 4/229 • Number of events 5 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
General disorders Other - Patient condition	1.3% 3/229 • Number of events 3 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	1.7% 2/118 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
General disorders Death	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Infections and infestations Systemic infection	2.2% 5/229 • Number of events 6 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	2.5% 3/118 • Number of events 4 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Infections and infestations Fever	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
General disorders Physical trauma	3.1% 7/229 • Number of events 8 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	4.2% 5/118 • Number of events 6 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
General disorders Abnormal laboratory values	0.87% 2/229 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Blood and lymphatic system disorders Hematological	0.87% 2/229 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	2.5% 3/118 • Number of events 3 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Nervous system disorders Neurological	3.9% 9/229 • Number of events 12 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	1.7% 2/118 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Gastrointestinal disorders Gastrointestinal	9.2% 21/229 • Number of events 24 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	9.3% 11/118 • Number of events 14 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Respiratory, thoracic and mediastinal disorders Pulmonary	9.6% 22/229 • Number of events 28 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	4.2% 5/118 • Number of events 14 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Reproductive system and breast disorders Genitourinary	3.5% 8/229 • Number of events 15 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Renal and urinary disorders Renal	3.9% 9/229 • Number of events 12 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Musculoskeletal and connective tissue disorders Musculoskeletal	7.9% 18/229 • Number of events 21 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	4.2% 5/118 • Number of events 6 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Psychiatric disorders Psychological	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	1.7% 2/118 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Skin and subcutaneous tissue disorders Integumentary	3.9% 9/229 • Number of events 11 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	1.7% 2/118 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
General disorders Head, eyes, ears, nose, throat (HEENT)	3.9% 9/229 • Number of events 10 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	4.2% 5/118 • Number of events 6 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Endocrine disorders Endocrine	2.6% 6/229 • Number of events 6 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	4.4% 10/229 • Number of events 11 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	3.4% 4/118 • Number of events 4 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
General disorders Multi-system failure	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders AV Block Intermittent	5.7% 13/229 • Number of events 14 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
General disorders Adverse Reaction - Allergic	0.00% 0/229 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	2.5% 3/118 • Number of events 8 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.

Other adverse events

Measure	MRI Group n=229 participants at risk Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant. MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment ImageReady System implant: Pacemaker and lead(s) implant	Control Group n=118 participants at risk Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups. ImageReady System implant: Pacemaker and lead(s) implant
Product Issues Oversensing - RA	0.87% 2/229 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Undersensing - RA	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	1.7% 2/118 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Other - PG system	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Oversensing - RV	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Rate response inappropriate	1.3% 3/229 • Number of events 3 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Inappropriate AV delay	0.44% 1/229 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	1.7% 2/118 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Pacemaker-mediated tachycardia (PMT)	2.6% 6/229 • Number of events 7 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	1.7% 2/118 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Hematoma - Pocket (> 30 days post-implant)	0.00% 0/229 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Extracardiac stimulation - RA	0.87% 2/229 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Dislodgment - RA	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Other - RA Lead	0.00% 0/229 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	1.7% 2/118 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Undersensing - RV	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Elevated threshold - RV	1.3% 3/229 • Number of events 3 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Extracardiac stimulation - RV	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	1.7% 2/118 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Surgical and medical procedures Post-surgical wound discomfort	2.2% 5/229 • Number of events 5 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	4.2% 5/118 • Number of events 6 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Surgical and medical procedures Post-surgical pocket hemorrhage	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Surgical and medical procedures Post-surgical infection (<= 30 days post-implant)	1.3% 3/229 • Number of events 3 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Surgical and medical procedures Chest pain	0.87% 2/229 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Surgical and medical procedures Hematoma - Pocket (<=30 days post-implant)	0.87% 2/229 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	2.5% 3/118 • Number of events 3 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Surgical and medical procedures Puncture site hematoma - Procedure	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Surgical and medical procedures Pneumothorax - Procedure	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Surgical and medical procedures Myocardial perforation without tamponade	0.00% 0/229 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Surgical and medical procedures Venous occlusion	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Surgical and medical procedures Other - PG system procedure	0.00% 0/229 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	1.7% 2/118 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Surgical and medical procedures Protocol Testing - Adverse reaction - General	0.87% 2/229 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Surgical and medical procedures Other - Protocol Testing	1.3% 3/229 • Number of events 3 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Dyspnea - Heart failure	0.87% 2/229 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Peripheral edema - Heart failure	0.00% 0/229 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Pulmonary edema - Heart failure	0.00% 0/229 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Hypotension - Heart failure	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Heart failure symptoms - Unspecified	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Multiple heart failure symptoms	1.3% 3/229 • Number of events 3 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	1.7% 2/118 • Number of events 3 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Other - Heart failure patient condition	1.3% 3/229 • Number of events 3 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Sinus bradycardia	0.87% 2/229 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Chronotropic incompetence	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	1.7% 2/118 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Ventricular tachycardia (VT)	1.3% 3/229 • Number of events 4 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Nonsustained ventricular tachycardia (NSVT)	11.4% 26/229 • Number of events 27 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	7.6% 9/118 • Number of events 10 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Atrial fibrillation (AF)	14.0% 32/229 • Number of events 40 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	9.3% 11/118 • Number of events 11 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Atrial flutter	1.3% 3/229 • Number of events 3 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	1.7% 2/118 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Sinus tachycardia	0.00% 0/229 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Other SVT (AVRT, AVNRT, EAT etc.)	4.4% 10/229 • Number of events 13 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	5.1% 6/118 • Number of events 9 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Premature ventricular contractions (PVC)	1.3% 3/229 • Number of events 3 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Hypotension	1.3% 3/229 • Number of events 6 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Hypertension	3.5% 8/229 • Number of events 9 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	3.4% 4/118 • Number of events 4 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Peripheral vascular disease	0.87% 2/229 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Aortic stenosis	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Mitral regurgitation	0.87% 2/229 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Syncope	0.87% 2/229 • Number of events 8 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	3.4% 4/118 • Number of events 4 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Dizziness	7.0% 16/229 • Number of events 16 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	3.4% 4/118 • Number of events 5 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Chest pain - Ischemic	0.87% 2/229 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Chest pain - Other	7.9% 18/229 • Number of events 24 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	5.9% 7/118 • Number of events 8 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Dyspnea	4.8% 11/229 • Number of events 11 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	2.5% 3/118 • Number of events 4 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Palpitations	3.5% 8/229 • Number of events 10 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Fatigue	2.2% 5/229 • Number of events 5 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	1.7% 2/118 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Multiple symptoms	0.87% 2/229 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	5.9% 7/118 • Number of events 7 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Cerebrovascular accident (CVA)	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Deep vein thrombosis (DVT)	0.87% 2/229 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Distal thromboemboli	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Pericardial effusion - Unrelated to procedure	0.00% 0/229 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Hematoma - Unrelated to procedure or device	1.3% 3/229 • Number of events 4 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders Other - Patient condition	2.6% 6/229 • Number of events 6 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	4.2% 5/118 • Number of events 5 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
General disorders Other - Patient condition	2.6% 6/229 • Number of events 6 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	5.1% 6/118 • Number of events 7 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Infections and infestations Systemic infection	0.44% 1/229 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
General disorders Physical trauma	11.4% 26/229 • Number of events 31 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	5.9% 7/118 • Number of events 8 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
General disorders Abnormal laboratory values	2.6% 6/229 • Number of events 8 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	2.5% 3/118 • Number of events 4 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Blood and lymphatic system disorders Hematological	1.3% 3/229 • Number of events 4 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	1.7% 2/118 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Nervous system disorders Neurological	8.3% 19/229 • Number of events 22 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	6.8% 8/118 • Number of events 10 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Gastrointestinal disorders Gastrointestinal	13.1% 30/229 • Number of events 35 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	7.6% 9/118 • Number of events 13 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Respiratory, thoracic and mediastinal disorders Pulmonary	4.8% 11/229 • Number of events 12 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	5.1% 6/118 • Number of events 6 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Reproductive system and breast disorders Genitourinary	6.1% 14/229 • Number of events 14 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	11.9% 14/118 • Number of events 21 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Renal and urinary disorders Renal	2.6% 6/229 • Number of events 6 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Musculoskeletal and connective tissue disorders Musculoskeletal	11.8% 27/229 • Number of events 32 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	18.6% 22/118 • Number of events 35 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Psychiatric disorders Psychological	2.6% 6/229 • Number of events 6 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Skin and subcutaneous tissue disorders Integumentary	9.2% 21/229 • Number of events 25 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	7.6% 9/118 • Number of events 9 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
General disorders Head, eyes, ears, nose, throat (HEENT)	15.7% 36/229 • Number of events 49 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	16.9% 20/118 • Number of events 28 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Endocrine disorders Endocrine	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	1.7% 2/118 • Number of events 2 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.44% 1/229 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Cardiac disorders AV Block Intermittent	5.2% 12/229 • Number of events 13 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.00% 0/118 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
Product Issues Extracardiac stimulation - LV	0.00% 0/229 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	0.85% 1/118 • Number of events 1 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
General disorders Adverse Reaction - Allergic	0.00% 0/229 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.	9.3% 11/118 • Number of events 13 • Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant. All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.

Additional Information

Kelly Aspinwall

Boston Scientific

Phone: 651-582-4560

Email: Kelly.Aspinwall@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee The restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor can request changes to the communication.
• Publication restrictions are in place

Restriction type: OTHER