Rivacor 7 VR-T DX DF4 ProMRI 429535Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04035479156800), received between Feb 17, 2021 and Jun 20, 2022 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Battery Problem” (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
- Battery Problem1
- Device Sensing Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Tachycardia1
- Wound Dehiscence1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2022Battery Problem; Battery Problem
IT WAS REPORTED THE DEVICE INTERROGATION SHOWED AN ERROR REGARDING ELEVATED POWER CONSUMPTION. BASED ON DATA ANALYSIS RESULTS IT WAS DECIDED TO REPORT THE INCIDENT. DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14747619 ↗InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 29 DAYS, IT WAS REPORTED THAT A WOUND DEHISCENCE WAS OBSERVED. PATIENT BROUGHT IN AND DEVICE AND LEAD EXPLANTED.
Patient problems: Wound Dehiscence
MAUDE report 12541232 ↗InjuryFeb 17, 2021Device Sensing Problem
IT WAS REPORTED THAT APPROX. ONE MONTH AFTER THE IMPLANTATION THE DEVICE DETECTED SUPRAVENTRICULAR TACHYCARDIA (SVT) INSTEAD OF VENTRICULAR TACHYCARDIA (VT). PATIENT WAS SYMPTOMATIC.
Patient problems: Tachycardia
MAUDE report 11337681 ↗
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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