Trial Outcomes & Findings for MOnitoring REsynchronization deviCes and cARdiac patiEnts (NCT NCT00885677)

Last Updated: 2025-07-02

Results Overview

The median delay from device-detected events to clinical decisions was considerably shorter in the Remote group compared to the Control group

Recruitment status

TERMINATED

Study phase

Target enrollment

918 participants

Primary outcome timeframe

1 year since the randomization

Results posted on

2025-07-02

Participant Flow

918 patients have been enrolled in the study, from 29/05/2009 (date of first enrollment) until 20/08/2014 (date of last enrollment).

918 subjects signed the Informed Consent Form. One of those subjects withdraw from the study prior randomization, therefore 917 subjects were randomized either to Study (462) or to Control (455) groups.

Participant milestones

Participant milestones
Measure	Study Group Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity. Medtronic CareLink® Network: Continuous monitoring via a disease remote management system. Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur.	Control Group Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
Overall Study STARTED	462	455
Overall Study Intention To Treat	437	428
Overall Study COMPLETED	279	277
Overall Study NOT COMPLETED	183	178

Reasons for withdrawal

Reasons for withdrawal
Measure	Study Group Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity. Medtronic CareLink® Network: Continuous monitoring via a disease remote management system. Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur.	Control Group Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
Overall Study Death	40	34
Overall Study Lost to Follow-up	15	13
Overall Study Protocol Violation	54	54
Overall Study premature study closure	41	44
Overall Study device/lead revision or replacement	7	6
Overall Study Heart transplantation	1	0
Overall Study Inclusion/exclusion not met	25	27

Baseline Characteristics

MOnitoring REsynchronization deviCes and cARdiac patiEnts

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Group n=437 Participants Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity. Medtronic CareLink® Network: Continuous monitoring via a disease remote management system. Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur.	Control Group n=428 Participants Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.	Total n=865 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 11 • n=5 Participants	67 years STANDARD_DEVIATION 10 • n=7 Participants	66 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	95 Participants n=5 Participants	116 Participants n=7 Participants	211 Participants n=5 Participants
Sex: Female, Male Male	342 Participants n=5 Participants	312 Participants n=7 Participants	654 Participants n=5 Participants
Region of Enrollment Greece	21 participants n=5 Participants	19 participants n=7 Participants	40 participants n=5 Participants
Region of Enrollment Netherlands	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants
Region of Enrollment Hungary	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment Italy	225 participants n=5 Participants	231 participants n=7 Participants	456 participants n=5 Participants
Region of Enrollment Israel	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Slovakia	12 participants n=5 Participants	11 participants n=7 Participants	23 participants n=5 Participants
Region of Enrollment France	85 participants n=5 Participants	77 participants n=7 Participants	162 participants n=5 Participants
Region of Enrollment Switzerland	35 participants n=5 Participants	33 participants n=7 Participants	68 participants n=5 Participants
Region of Enrollment Spain	46 participants n=5 Participants	43 participants n=7 Participants	89 participants n=5 Participants
History of AF History of AF	89 participants n=5 Participants	62 participants n=7 Participants	151 participants n=5 Participants
History of AF No History of AF	340 participants n=5 Participants	361 participants n=7 Participants	701 participants n=5 Participants
History of AF Missing	8 participants n=5 Participants	5 participants n=7 Participants	13 participants n=5 Participants
History of Myocardial Infarction With History of Myocardial Infarction	164 participants n=5 Participants	173 participants n=7 Participants	337 participants n=5 Participants
History of Myocardial Infarction Without History of Myocardial Infarction	262 participants n=5 Participants	252 participants n=7 Participants	514 participants n=5 Participants
History of Myocardial Infarction Missing	11 participants n=5 Participants	3 participants n=7 Participants	14 participants n=5 Participants
LVEF	27.3 % STANDARD_DEVIATION 6.6 • n=5 Participants	27.4 % STANDARD_DEVIATION 6.0 • n=7 Participants	27.3 % STANDARD_DEVIATION 6.3 • n=5 Participants

PRIMARY outcome

Timeframe: 1 year since the randomization

Population: Phase 1: A total of 154 patients were enrolled from May 2009 through April 2010 from 32 centers in 6 different countries (France, Hungary, Israel, Italy, Spain, and Switzerland). The final patient cohort object of analysis comprised 148 patients (76 in the Remote group and 72 in the Control group)

The median delay from device-detected events to clinical decisions was considerably shorter in the Remote group compared to the Control group

Outcome measures

Outcome measures
Measure	Study Group n=76 Participants Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity. Medtronic CareLink® Network: Continuous monitoring via a disease remote management system. Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur.	Control Group n=72 Participants Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
Phase 1: Median Time Between Event Onset Time and Clinical Decision for Each Subject.	2 days Interval 1.0 to 4.0	29 days Interval 3.0 to 51.0

PRIMARY outcome

Timeframe: 2 years after randomization

Population: All subjects in analysis were included in the primary endpoint analysis

Time to first event

Outcome measures

Outcome measures
Measure	Study Group n=437 Participants Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity. Medtronic CareLink® Network: Continuous monitoring via a disease remote management system. Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur.	Control Group n=428 Participants Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
Phase 2: Combined Endpoint of Death From Any Cause, Cardiovascular and Device-related Hospitalizations (at Least 48 Hours Stay), Calculated as Number of Subjects With at Least One Event	134 participants	126 participants

Adverse Events

Study Group

Serious events: 184 serious events

Other events: 68 other events

Deaths: 0 deaths

Control Group

Serious events: 168 serious events

Other events: 85 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Valentina Amori

Medtronic EMEA RCC

Phone: 3425417863

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Study Group n=462 participants at risk Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity. Medtronic CareLink® Network: Continuous monitoring via a disease remote management system. Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur.	Control Group n=455 participants at risk Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
Blood and lymphatic system disorders Anaemias nonhaemolytic and marrow depression	0.65% 3/462 • Number of events 6 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.44% 2/455 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Cardiac disorders Arteriosclerosis, stenosis, vascular insufficiency and necrosis	2.2% 10/462 • Number of events 12 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	2.4% 11/455 • Number of events 11 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Cardiac disorders Cardiac arrhythmias	3.5% 16/462 • Number of events 22 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	4.2% 19/455 • Number of events 21 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Cardiac disorders Cardiac disorder signs and symptoms	3.5% 16/462 • Number of events 16 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	2.6% 12/455 • Number of events 14 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Cardiac disorders Cardiac valve disorders	0.43% 2/462 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.66% 3/455 • Number of events 3 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Cardiac disorders Coronary artery disorders	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.88% 4/455 • Number of events 4 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Cardiac disorders Heart failures	16.5% 76/462 • Number of events 132 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	16.0% 73/455 • Number of events 133 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Cardiac disorders Myocardial disorders	0.00% 0/462 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.22% 1/455 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Cardiac disorders Surgical and medical procedures	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.44% 2/455 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Cardiac disorders Vascular disorders	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.00% 0/455 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Endocrine disorders Thyroid disorder	0.22% 1/462 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.66% 3/455 • Number of events 3 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Eye disorders Anterior eye structural change, deposit and degeneration	0.43% 2/462 • Number of events 3 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.22% 1/455 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Gastrointestinal disorders Abdominal hernias and other abdominal wall conditions	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.88% 4/455 • Number of events 4 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Gastrointestinal disorders Gastrointestinal haemorrhages NEC	0.22% 1/462 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.22% 1/455 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Gastrointestinal disorders Gastrointestinal infection	0.00% 0/462 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.22% 1/455 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Gastrointestinal disorders Gastrointestinal inflammatory conditions	0.00% 0/462 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.22% 1/455 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Gastrointestinal disorders Gastrointestinal motility and defaecation conditions	0.43% 2/462 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.22% 1/455 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Gastrointestinal disorders Gastrointestinal signs and symptoms	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.66% 3/455 • Number of events 3 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
General disorders Fatal outcome	4.5% 21/462 • Number of events 21 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	4.4% 20/455 • Number of events 20 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
General disorders General system disorders NEC	1.5% 7/462 • Number of events 7 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	1.8% 8/455 • Number of events 9 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
General disorders Tissue disorder	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.00% 0/455 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
General disorders Tissue disorders NEC	0.00% 0/462 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.22% 1/455 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Hepatobiliary disorders Gallbladder disorders	0.43% 2/462 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.00% 0/455 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Infections and infestations Infections - pathogen unspecified	0.43% 2/462 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.44% 2/455 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Infections and infestations Infections and infestations	0.87% 4/462 • Number of events 4 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.88% 4/455 • Number of events 4 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Injury, poisoning and procedural complications Bone and joint injuries	1.1% 5/462 • Number of events 5 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.66% 3/455 • Number of events 3 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Injury, poisoning and procedural complications Cardiac disorder signs and symptoms	0.00% 0/462 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.22% 1/455 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Injury, poisoning and procedural complications Injuries NEC	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.44% 2/455 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Injury, poisoning and procedural complications Medication errors	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.00% 0/455 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Injury, poisoning and procedural complications Procedural and device related injuries and complications NEC	6.9% 32/462 • Number of events 33 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	5.7% 26/455 • Number of events 28 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Investigations Cardiac and vascular investigations (excl enzyme tests)	0.43% 2/462 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.22% 1/455 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Investigations Gastrointestinal investigations	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.00% 0/455 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Metabolism and nutrition disorders Diabetic complications	0.65% 3/462 • Number of events 4 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.44% 2/455 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Metabolism and nutrition disorders Metabolism disorder	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.22% 1/455 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders NEC	1.5% 7/462 • Number of events 9 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.44% 2/455 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor	1.3% 6/462 • Number of events 8 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	1.8% 8/455 • Number of events 9 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Nervous system disorders Central nervous system vascular disorders	0.65% 3/462 • Number of events 3 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.88% 4/455 • Number of events 4 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Nervous system disorders Headaches	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.00% 0/455 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Nervous system disorders Increased intracranial pressure and hydrocephalus	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.22% 1/455 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Nervous system disorders Neurological disorders NEC	1.1% 5/462 • Number of events 5 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.00% 0/455 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)

Other adverse events
Measure	Study Group n=462 participants at risk Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity. Medtronic CareLink® Network: Continuous monitoring via a disease remote management system. Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur.	Control Group n=455 participants at risk Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
Blood and lymphatic system disorders Anaemias nonhaemolytic and marrow depression	0.43% 2/462 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.00% 0/455 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Cardiac disorders Arteriosclerosis, stenosis, vascular insufficiency and necrosis	1.3% 6/462 • Number of events 6 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	1.8% 8/455 • Number of events 8 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Cardiac disorders Cardiac arrhythmias	2.2% 10/462 • Number of events 12 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	2.2% 10/455 • Number of events 10 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Cardiac disorders Cardiac disorder signs and symptoms	1.3% 6/462 • Number of events 6 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.88% 4/455 • Number of events 4 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Cardiac disorders Coronary artery disorders	0.00% 0/462 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.44% 2/455 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Cardiac disorders Heart failures	2.2% 10/462 • Number of events 17 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	4.2% 19/455 • Number of events 27 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Cardiac disorders Myocardial disorders	0.00% 0/462 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.22% 1/455 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Ear and labyrinth disorders Hearing disorders	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.00% 0/455 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Endocrine disorders Thyroid disorder	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.22% 1/455 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Eye disorders Anterior eye structural change, deposit and degeneration	0.43% 2/462 • Number of events 3 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.00% 0/455 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Eye disorders Infections - pathogen unspecified	0.00% 0/462 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.22% 1/455 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Gastrointestinal disorders Abdominal hernias and other abdominal wall conditions	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.22% 1/455 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Gastrointestinal disorders Gastrointestinal signs and symptoms	0.00% 0/462 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.44% 2/455 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
General disorders Device issues	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.00% 0/455 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
General disorders General system disorders NEC	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	1.3% 6/455 • Number of events 7 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Infections and infestations Infections and infestations	0.00% 0/462 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.44% 2/455 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Injury, poisoning and procedural complications Bone and joint injuries	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.00% 0/455 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Injury, poisoning and procedural complications Injuries NEC	0.43% 2/462 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.00% 0/455 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Injury, poisoning and procedural complications Procedural and device related injuries and complications NEC	3.7% 17/462 • Number of events 17 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	2.9% 13/455 • Number of events 15 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Investigations Cardiac and vascular investigations (excl enzyme tests)	0.43% 2/462 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.66% 3/455 • Number of events 3 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Injury, poisoning and procedural complications Cardiac disorder signs and symptoms	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.00% 0/455 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Investigations Gastrointestinal investigations	0.00% 0/462 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.22% 1/455 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Metabolism and nutrition disorders Diabetic complications	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.22% 1/455 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Metabolism and nutrition disorders Metabolism disorder	0.43% 2/462 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.00% 0/455 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders NEC	0.22% 1/462 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.00% 0/455 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.00% 0/455 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Nervous system disorders Headaches	0.00% 0/462 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.22% 1/455 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Nervous system disorders Movement disorders (incl parkinsonism)	0.00% 0/462 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.44% 2/455 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Nervous system disorders Neurological disorders NEC	0.65% 3/462 • Number of events 3 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	1.8% 8/455 • Number of events 9 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Nervous system disorders Sleep disturbances (incl subtypes)	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.22% 1/455 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Renal and urinary disorders Renal disorder	0.43% 2/462 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.00% 0/455 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Renal and urinary disorders Ureteric disorders	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.88% 4/455 • Number of events 4 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Respiratory, thoracic and mediastinal disorders Respiratory tract infections	1.1% 5/462 • Number of events 5 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.88% 4/455 • Number of events 5 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Skin and subcutaneous tissue disorders Epidermal and dermal conditions	0.00% 0/462 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.22% 1/455 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Surgical and medical procedures Cardiac therapeutic procedures	1.1% 5/462 • Number of events 5 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	1.5% 7/455 • Number of events 7 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Surgical and medical procedures Head and neck therapeutic procedures	0.00% 0/462 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.22% 1/455 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Vascular disorders Aneurysms and artery dissections	0.22% 1/462 • Number of events 1 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.44% 2/455 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Surgical and medical procedures Decreased and nonspecific blood pressure disorders and shock	0.00% 0/462 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.44% 2/455 • Number of events 2 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
Vascular disorders Vascular disorders NEC	0.00% 0/462 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)	0.66% 3/455 • Number of events 3 • Adverse events have been collected since subject enrollment until subjct exit/death. The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic: * Serious Adverse Events (SAE); * Serious Adverse Device Effects (SADE); * Serious Adverse Procedure related Events (SAPE); * Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)