Ilivia 7 HF-T QP DF4 IS4 ProMRI 404621Recalls & 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 implantable defibrillator has 133 reports, many describing infections around the device and early battery warnings, with some devices unable to be read by a programmer. The reports mention 2 deaths and 96 injuries, and no recalls name this device. Reports fell to 2 in the last 12 months from 9 in the previous 12.
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
- 133
- Deaths reported
- 2
- Injuries reported
- 96
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 04035479142087), received between Jun 15, 2018 and Aug 11, 2026 — classified as 2 deaths, 96 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (13 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 Problem91
- Premature Elective Replacement Indicator13
- Premature End-of-Life Indicator11
- Failure to Interrogate8
- Inappropriate/Inadequate Shock/Stimulation3
- Over-Sensing3
- Premature Discharge of Battery2
- Connection Problem1
Patient problems
- Unspecified Infection69
- No Clinical Signs, Symptoms or Conditions27
- No Known Impact Or Consequence To Patient9
- Pocket Erosion7
- Pain6
- Hematoma4
- Pleural Effusion3
- Pneumothorax3
Recent adverse event reports
The 25 most recent of 133 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2026Premature End-of-Life Indicator
Device explanted due to EOL 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 50213493 ↗InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem
MDT AFFERA ABLATION TOOL CAUSED AN ADVERSE EVENT TO THE PATIENT. THE PATIENT WAS EXTERNALLY DEFIBRILLATED AND IS STABLE. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Tachycardia
MAUDE report 24344867 ↗MalfunctionJun 11, 2025Failure to Interrogate; Extracardiac stimulation; Failure to Interrogate; Extracardiac stimulation
THIS DEVICE WAS EXPLANTED DUE TO UNABLE TO INTERROGATE AND POCKET STIMULATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Undesired Nerve Stimulation
MAUDE report 22184996 ↗MalfunctionMay 29, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator
THIS DEVICE WAS EXPLANTED DUE TO EOS LIKELY CAUSED BY INAPPROPRIATE SHOCKS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22105338 ↗InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO INFECTION AND EROSION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 21972080 ↗InjuryApr 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 BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 21909470 ↗MalfunctionApr 23, 2025Failure to Interrogate; Premature End-of-Life Indicator; Failure to Interrogate; Premature End-of-Life Indicator
THIS DEVICE WAS EXPLANTED DUE TO IT CANNOT BE INTERROGATED AND IS SHOWING EOS 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 21890514 ↗MalfunctionMar 13, 2025Failure to Interrogate; Failure to Interrogate
DEVICE COULD NOT BE INTERROGATED AND 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 21597048 ↗MalfunctionJan 27, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE WAS EXPLANTED DUE TO EOS. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21240163 ↗InjuryJan 16, 2025Failure to Interrogate; Inappropriate/Inadequate Shock/Stimulation; Failure to Interrogate; Inappropriate/Inadequate Shock/Stimulation
DEVICE WAS EXPLANTED DUE TO ERI AND UNABLE TO INTERROGATE. THE PATIENT WAS SHOCKED IN THE ER EVEN THOUGH TWO MAGNETS WERE PLACED OVER THE ICD. THE PATIENT HAS AN LVAD IMPLANT WHICH IS THOUGHT TO BE INTERFERING. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21172823 ↗MalfunctionNov 7, 2024Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE WENT FROM ERI TO EOS AFTER 68 SHOCKS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20631225 ↗MalfunctionAug 22, 2024Premature End-of-Life Indicator; Premature End-of-Life Indicator
THIS DEVICE WAS EXPLANTED DUE TO EOS. 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 20030212 ↗InjuryAug 14, 2024Adverse 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 19983185 ↗InjuryApr 25, 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 19188125 ↗InjuryApr 15, 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 19112426 ↗InjuryApr 1, 2024Adverse 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 19016828 ↗MalfunctionDec 14, 2023Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI. HIGH LV THRESHOLDS REPORTED. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18331032 ↗InjuryOct 26, 2023Adverse 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 18016785 ↗MalfunctionMay 18, 2023Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO BATTERY DEPLETION DUE TO HIGH OUTPUT PROGRAMMED. NO ADVERSE PATIENT EVENTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16952766 ↗MalfunctionApr 11, 2023Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE EXPLANTED DUE TO EOS CAUSED BY MULTIPLE INAPPROPRIATE SHOCKS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16712908 ↗InjuryMar 14, 2023Adverse 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 16541680 ↗MalfunctionFeb 14, 2023Premature End-of-Life Indicator; Premature End-of-Life Indicator
THIS DEVICE WAS EXPLANTED DUE TO EOS. 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 16375567 ↗InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS UNDERGOING POCKET REVISION DUE TO A FALL ALTERING THE POCKET. DEVICE WAS EXPLANTED DUE TO SUSPECTED POCKET EROSION. LEADS WERE LEFT IN PLACE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Fall; Pocket Erosion
MAUDE report 16285829 ↗InjuryJan 19, 2023Adverse 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 16206016 ↗InjuryDec 12, 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 15964946 ↗
Other Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) devices
- Gallant™ CDHFA500QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)2 recalls58 deaths8,401 reports
- Quartet™ 1458Q-86St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)207 deaths6,631 reports
- QUADRA ASSURA MP™ CD3369-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)103 deaths6,084 reports
- VIGILANT™ X4 CRT-D G247Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)17 deaths2,066 reports
- Quadra Assura™ CD3365-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)53 deaths2,056 reports
- Cobalt™ XT HF Quad CRT-D MRI SureScan™ DTPA2QQMedtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)4 recalls40 deaths1,639 reports
- Unify Assura™ CD3357-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)54 deaths1,784 reports
- Unify Assura™ CD3357-40CSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)56 deaths1,588 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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