Rivacor 5 DR-T DF4 ProMRI 429563Recalls & 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
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04035479156893), received between Oct 6, 2020 and Jun 11, 2025 — classified as 1 injury, 3 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Battery Problem1
- Failure to Interrogate1
- Impedance Problem1
- Over-Sensing1
- Signal Artifact/Noise1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 22189106 ↗MalfunctionJul 14, 2022Signal Artifact/Noise; Over-Sensing; Impedance Problem; Signal Artifact/Noise; Over-Sensing; Impedance Problem
IT WAS REPORTED THAT SHOCK IMPEDANCE VALUES OUT OF RANGE AND OVERSENSING WITH ARTEFACTS WERE OBSERVED VIA HOME MONITORING APPROX. ONE WEEK AFTER THE IMPLANTATION. IT WAS DECIDED TO EXCHANGE THE ICD AND THE LEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15014909 ↗MalfunctionJan 18, 2021Battery Problem; Battery Problem
AFTER AN IMPLANTATION PERIOD OF APPROX. 9 MONTHS, IT WAS OBSERVED THAT THE ICD WAS NOT ABLE TO CHARGE THE CAPACITOR AND DRAINED THE BATTERY BY TRYING OVER AND OVER. THE ICD WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11188829 ↗MalfunctionOct 6, 2020Failure to Interrogate; Failure to Interrogate
AFTER AN IMPLANTATION PERIOD OF APPROX. 3 MONTHS, IT WAS REPORTED THAT THE ICD WAS NOT INTERROGABLE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10638248 ↗
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- Ilesto 7 DR-T DF-1 US 383562BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER79 reports
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- Ilivia Neo 7 DR-T DF-1 ProMRI 429529BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER1 death56 reports
- Itrevia 7 DR-T DF4 392426BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER1 death48 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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