Ilivia Neo 7 DR-T DF-1 ProMRI 429529Recalls & 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 Neo 7 is an implanted dual-chamber defibrillator that delivers pacing and shock therapy for heart rhythm problems. Most of the 56 adverse event reports describe the device being taken out of the body because of infection, along with pocket erosion at the implant site; a smaller number mention the battery running out early, the device shifting position, or it failing to be read during a check. Reports include 1 death and 43 injuries. 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
- 56
- Deaths reported
- 1
- Injuries reported
- 43
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 04035479156749), received between Dec 2, 2020 and Aug 26, 2026 — classified as 1 death, 43 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (3 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
- Adverse Event Without Identified Device or Use Problem45
- Premature Elective Replacement Indicator3
- Premature End-of-Life Indicator3
- Battery Problem2
- Failure to Interrogate1
- Impedance Problem1
- Loose or Intermittent Connection1
- Migration or Expulsion of Device1
Patient problems
- Unspecified Infection37
- No Clinical Signs, Symptoms or Conditions12
- Pocket Erosion6
- Endocarditis1
- Implant Pain1
- Skin Inflammation/ Irritation1
- Syncope/Fainting1
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 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 50456381 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 24673989 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
THIS DEVICE WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 24365050 ↗DeathFeb 6, 2026Adverse Event Without Identified Device or Use Problem
PATIENT DECEASED (B)(6) 2026 AFTER (B)(6) 2026 GENERATOR CHANGEOUT. PATIENTS FAMILY BELIEVES DEATH IS RELATED TO THIS NEW DEVICE, IMPLANTING PHYSICIAN DOES NOT. NO EVENTS WERE RECORDED FOR DATE OF DEATH. THERE HAS BEEN AN AUTOPSY AND THE RESULTS ARE UNKNOWN. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24278442 ↗InjuryFeb 3, 2026Adverse 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 24249114 ↗InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
DUE TO INFECTION, POCKET WAS OPENED AND RINSED. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 24241995 ↗InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 23704561 ↗InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO POCKET EROSION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion
MAUDE report 23491578 ↗InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO POCKET EROSION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion
MAUDE report 23083420 ↗InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 22900014 ↗InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
TOTAL SYSTEM EXTRACTION SECONDARY TO ENDOCARDITIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Endocarditis
MAUDE report 22872974 ↗InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 22519660 ↗InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS DEVICE WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 21859343 ↗MalfunctionMar 13, 2025Premature Elective Replacement Indicator; Premature 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 21596860 ↗InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 21224655 ↗InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 21080147 ↗InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO POCKET EROSION AND INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 20733930 ↗InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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 20640506 ↗MalfunctionOct 23, 2024Impedance Problem; Impedance Problem
DEVICE WAS EXPLANTED DUE TO UNSTABLE SHOCK IMPEDANCES, FLUCTUATING TO MORE THAN 130 AT TIMES. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20514695 ↗InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 20300435 ↗InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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 20141691 ↗InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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 19761072 ↗MalfunctionJan 26, 2024Premature End-of-Life Indicator; Battery Problem; Premature End-of-Life Indicator; Battery Problem
DEVICE WENT FROM BOS TO EOS OVERNIGHT. IT WAS UNCLEAR WHETHER THE PATIENT UNDERWENT ANY PROCEDURES OR HAD ANY MRI SCANS DURING THIS TIME. DEVICE CURRENTLY 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 18588926 ↗MalfunctionJan 4, 2024Premature 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 18446550 ↗InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse 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 18217205 ↗
Other DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER devices
- Rivacor 7 DR-T DF4 ProMRI 429534BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER2 deaths286 reports
- Iperia 7 DR-T DF4 ProMRI 392423BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER3 deaths256 reports
- Ilivia 7 DR-T DF4 ProMRI 404623BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER2 deaths233 reports
- Iperia 7 DR-T DF-1 ProMRI 392409BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER93 reports
- Ilesto 7 DR-T DF-1 US 383562BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER79 reports
- Ilivia 7 DR-T DF-1 ProMRI 404622BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER74 reports
- Itrevia 7 DR-T DF4 392426BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER1 death48 reports
- Lumax 740 DR-T 365606BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER1 death47 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.
How reports and recalls are matched · Editorial policy · Report an error on this page