Ilivia Neo 7 VR-T DF-1 ProMRI 429531Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04035479156763), received between Dec 19, 2019 and Sep 1, 2026 — classified as 18 injuries, 5 malfunctions.
The most frequently reported specific device problem is “High impedance” (2 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 Problem17
- High impedance2
- Battery Problem1
- Migration or Expulsion of Device1
- Premature Elective Replacement Indicator1
- Premature End-of-Life Indicator1
Patient problems
- Unspecified Infection15
- No Clinical Signs, Symptoms or Conditions4
- Cardiac Tamponade1
- No Known Impact Or Consequence To Patient1
- Pocket Erosion1
- Wound Dehiscence1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjurySep 1, 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 50552158 ↗InjuryJun 30, 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 25667271 ↗InjuryJun 23, 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 25595898 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
THIS DEVICE WAS EXPLANTED DUE TO POCKET EROSION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion
MAUDE report 25049679 ↗InjuryApr 13, 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 24867892 ↗InjuryNov 4, 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 23472055 ↗InjuryAug 25, 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 BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 22890632 ↗MalfunctionMay 14, 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 22019962 ↗InjuryNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 20772649 ↗MalfunctionSep 30, 2024Premature 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 20333719 ↗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 20141690 ↗InjuryAug 14, 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 19988270 ↗InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 19152001 ↗InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 16712937 ↗InjuryNov 30, 2022Adverse 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 15886533 ↗InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2022 (UNKNOWN DATE), DUE TO INFECTION AT THE POCKET AREA (WOUNDED AREA), THE RELEVANT ILIVIA AND LINOX WERE REMOVED FROM THE PATIENT. THE DEVICE IS NOT AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 13934473 ↗MalfunctionJul 13, 2021Battery Problem; Battery Problem
IT WAS REPORTED THAT THE DEVICE WAS PROPHYLACTICALLY EXPLANTED AND REPLACED DUE TO THE FIELD SAFETY CORRECTIVE ACTION, BIO-LQC. THE ICD WAS IMPLANTED AND ACTIVE FOR APPROX. 10 MONTHS. PLEASE NOTE THIS ICD IS AFFECTED BY A FIELD SAFETY CORRECTIVE ACTION, BIO-LQC, INITIATED IN MARCH 2021.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12158382 ↗InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT (B)(6) 2021, THE GENERATOR WAS REMOVED FROM THE PATIENT DUE TO INFECTION. THE LEAD WAS CAPPED.
Patient problems: Unspecified Infection
MAUDE report 12129614 ↗InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN AUTOMATIC EMAIL NOTIFICATION WAS RECEIVED REGARDING AN ADVERSE EVENT THAT OCCURRED DURING THE DX-AF STUDY. DATABASE INFORMATION WAS FORWARDED AND IS SUMMARIZED BELOW. THE DIAGNOSIS/CAUSE WAS TAMPONADE AND WAS DETERMINED TO BE MODERATE SEVERITY AND THE SYMPTOMS INCLUDED DECREASE OF BLOOD PRESSURE. THE CORRECTIVE ACTION TAKEN WAS PERICARDIAL PUNCTURE. THE EVENT RESULTED IN IN-PATIENT HOSPITALIZATION ON (B)(6) 2021. THE OUTCOME OF THE EVENT IS ON-GOING AND THE RELATIONSHIP OF THE ADVERSE EVENT TO MEDICAL DEVICE IS NOT RELATED TO THE ICD OR LEAD IMPLANT BUT RELATED TO THE IMPLANTATION PROCEDURE AS INDICATED ON THE STUDY DATABASE. PATIENT WAS OBSERVED FOR 24 HOURS POST PERICARDIAL PUNCTURE AND PATIENT WAS RELEASED ON (B)(6) 2021.
Patient problems: Cardiac Tamponade
MAUDE report 11416460 ↗MalfunctionJan 21, 2021High impedance; High impedance
HIGH SHOCK IMPEDANCE WAS REPORTED FOLLOWING A DEVICE CHANGE OUT ON (B)(6) 2021. LEAD WAS TESTED, POCKET MANIPULATION WAS UNABLE TO PRODUCE NOISE. LEAD IS A COMPETITOR LEAD, PHYSICIAN IS NOT SURE IF THE HIGH IMPEDANCE IS CAUSED BY THE LEAD OR THE DEVICE/ POCKET. 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 11210944 ↗InjuryDec 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 11083699 ↗InjuryNov 23, 2020Migration or Expulsion of Device; Migration or Expulsion of Device
DEVICE WAS EXPLANTED BECAUSE THEY DEVICE POCKET NEVER HEALED AND THE WOUND WAS OPENING. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Patient problems: Wound Dehiscence
MAUDE report 10888238 ↗MalfunctionDec 19, 2019High impedance; High impedance
AFTER REPLACEMENT OF THE PREVIOUS ICD, IT WAS REPORTED THAT THE SHOCK IMPEDANCE VALUES WERE TOO HIGH.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9492249 ↗
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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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