Rivacor 5 VR-T DF4 ProMRI 429565Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04035479156916), received between Sep 14, 2021 and Aug 7, 2022 — classified as 1 death, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Convert Rhythm” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Failure to Convert Rhythm1
- Low impedance1
- Under-Sensing1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Asystole1
- Tachycardia1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2022Under-Sensing; Under-Sensing
AFTER AN IMPLANTATION PERIOD OF APPROX. 34 MONTHS, IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH AN ONGOING VT. IT WAS OBSERVED THAT THE ICD DID NOT IDENTIFY THE VT AS SUCH AND DID NOT DELIVER THERAPY.
Patient problems: Tachycardia
MAUDE report 15180788 ↗MalfunctionAug 1, 2022Low impedance; Low impedance
AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 15 MONTHS IT WAS REPORTED THAT LOW SHOCK IMPEDANCE WAS OBSERVED. THIS ICD WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15142260 ↗DeathJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DIED APPROX. 2 MONTHS AFTER THE DEVICE IMPLANTATION. THE PHYSICIAN WISHES THE EVALUATION OF THE DEVICE MEMORY.
Patient problems: Asystole
MAUDE report 15019823 ↗MalfunctionSep 14, 2021Failure to Convert Rhythm; Failure to Convert Rhythm
20 DAYS AFTER IMPLANTATION, NON EFFECTIVE MAXIMUM ENERGY SHOCKS WERE REPORTED. THE DEVICE AND THE LEAD WERE EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12468437 ↗
Other Implantable cardioverter defibrillator (non-CRT) devices
- EMBLEM™ MRI S-ICD A219Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 recalls36 deaths15,404 reports
- EMBLEM™ S-ICD A209Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall7 deaths6,788 reports
- EMBLEM™ S-ICD 3501Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)7 deaths4,936 reports
- Cobalt™ XT DR MRI SureScan™ DDPA2D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)3 recalls30 deaths1,603 reports
- ENDOTAK RELIANCE® G 0185Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,632 reports
- VIGILANT™ EL ICD DR D233Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,563 reports
- Evera MRI™ XT DR SureScan® DDMB1D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)1 recall35 deaths1,426 reports
- Durata™ 7122St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)27 deaths1,377 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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