Ilivia 7 DR-T DF4 ProMRI 404623Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Ilivia 7 implantable dual-chamber defibrillator has 234 adverse event reports, including 93 injuries and 2 deaths. The reports mostly describe the battery indicator reaching replacement or end-of-life early, often with unexpected battery behavior, leading to the device being removed. Unspecified infection is listed in 64 reports. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 233
- Deaths reported
- 2
- Injuries reported
- 92
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 233 adverse event reports that list this exact device (DI 04035479142100), received between Jun 14, 2018 and Sep 8, 2026 — classified as 2 deaths, 92 injuries, 139 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (107 reports).
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
- Premature Elective Replacement Indicator107
- Adverse Event Without Identified Device or Use Problem77
- Premature End-of-Life Indicator24
- Failure to Interrogate10
- Battery Problem8
- Inappropriate/Inadequate Shock/Stimulation6
- Ambient Noise Problem2
- Premature Discharge of Battery2
Patient problems
- No Clinical Signs, Symptoms or Conditions136
- Unspecified Infection64
- No Known Impact Or Consequence To Patient13
- Endocarditis4
- Pocket Erosion4
- Shock from Patient Lead(s)3
- Ventricular Fibrillation2
- Wound Dehiscence2
Recent adverse event reports
The 25 most recent of 233 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2026Premature End-of-Life Indicator; Premature Elective Replacement Indicator
Device explanted due to ERI/EOS indication with unexpected battery behavior. 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 50671516 ↗InjuryAug 17, 2026Premature Elective Replacement Indicator
This device was explanted due to ERI with unexpected battery behavior. No adverse patient events were reported. Should additional information become available, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50289643 ↗InjuryApr 13, 2026Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI INDICATION WITH UNEXPECTED BATTERY BEHAVIOR. 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 24867857 ↗InjuryApr 13, 2026Failure to Interrogate; Premature End-of-Life Indicator
DEVICE EXPLANTED DUE TO EOS INDICATION WITH UNEXPECTED BATTERY BEHAVIOR AND UNABLE TO INTERROGATE. 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 24867770 ↗InjuryApr 10, 2026Premature End-of-Life Indicator
THIS DEVICE WAS EXPLANTED DUE TO EOS WITH UNEXPECTED BATTERY BEHAVIOR. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845138 ↗InjuryMar 12, 2026Premature End-of-Life Indicator
SUDDEN BATTERY DEPLETION TO EOS ALERT AND NO THERAPIES. DEVICE CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24583675 ↗InjuryMar 11, 2026Failure to Interrogate; Premature End-of-Life Indicator
THIS DEVICE WAS EXPLANTED DUE TO EOS AND COULD NOT BE INTERROGATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24573086 ↗MalfunctionMar 3, 2026Over-Sensing; Premature End-of-Life Indicator; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
THE PATIENT HAD PRESENTED TO THE HOSPITAL AFTER RECEIVING SHOCK THERAPY. NOISE HAD BEEN DETECTED, AND INAPPROPRIATE THERAPY DUE TO OVERSENSING. MULTIPLE SHOCKS HAD BEEN DELIVERED, AND THE DEVICE HAD REACHED EOS. A REVISION IS SCHEDULED FOR FEBRUARY 27TH TO CHECK THE LEAD AND REPLACE THE ICD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24495765 ↗InjuryFeb 23, 2026Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI INDICATION WITH UNEXPECTED BATTERY BEHAVIOR. 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 24417206 ↗InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 24291762 ↗InjuryJan 13, 2026Premature Elective Replacement Indicator
DEVICE IS AT ERI INDICATION WITH UNEXPECTED BATTERY BEHAVIOR. NO ADVERSE PATIENT EVENTS WERE REPORTED. DEVICE CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058538 ↗MalfunctionJan 12, 2026Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI INDICATION WITH UNEXPECTED BATTERY BEHAVIOR. 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 24041618 ↗MalfunctionDec 23, 2025Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THIS DEVICE SHOWS ERI WITH UNEXPECTED BATTERY BEHAVIOR. DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23877021 ↗MalfunctionNov 10, 2025Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI INDICATION WITH UNEXPECTED BATTERY BEHAVIOR. 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 23512687 ↗MalfunctionAug 25, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE EXPLANTED DUE TO EOS INDICATION WITH UNEXPECTED BATTERY BEHAVIOR. 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 22884721 ↗MalfunctionAug 19, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator
THIS DEVICE SHOWS EOS WITH UNEXPECTED BATTERY BEHAVIOR. DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22839556 ↗InjuryAug 18, 2025Failure to Interrogate; Premature Elective Replacement Indicator; Failure to Interrogate; Premature Elective Replacement Indicator
DEVICE COULD NOT BE INTERROGATED BY TWO DIFFERENT PROGRAMMERS. LAST IN PERSON CHECK IN FEB 2025 BATTERY WAS AT 21 PERCENT. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22835367 ↗InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO BLOOD INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 22725624 ↗InjuryJul 30, 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 22669416 ↗InjuryJul 22, 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 22566730 ↗MalfunctionJul 17, 2025Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THIS DEVICE SHOWS ERI WITH UNEXPECTED BATTERY BEHAVIOR. DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22538601 ↗InjuryJul 7, 2025Premature End-of-Life Indicator; Inappropriate/Inadequate Shock/Stimulation; Premature End-of-Life Indicator; Inappropriate/Inadequate Shock/Stimulation
THIS DEVICE WAS EXPLANTED DUE TO EOS LIKELY CAUSED BY 22 INAPPROPRIATE SHOCKS DELIVERED DUE TO FRACTURED RV LEAD WITH NOISE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22411877 ↗InjuryMay 23, 2025Failure to Interrogate; Failure to Interrogate
DEVICE COULD NOT BE INTERROGATED. POSSIBLE BATTERY ISSUE. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22077835 ↗MalfunctionMay 20, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator
THIS DEVICE WAS EXPLANTED DUE TO EOS WITH UNEXPECTED BATTERY BEHAVIOR. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22056757 ↗MalfunctionMay 15, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator
THIS DEVICE WAS EXPLANTED DUE TO EOS WITH UNEXPECTED BATTERY BEHAVIOR. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22030996 ↗
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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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