Inventra 7 VR-T DX DF-1 ProMRI 399436Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Inventra 7 heart defibrillator has 533 adverse event reports, with 1 death and 96 injuries. Most reports describe an early warning that the battery needed replacement, along with unexpected battery behavior, and several describe the device being removed for that reason. No recalls name this device. Reports fell from 66 in the prior 12 months to 39 in the last 12 months.
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
- 534
- Deaths reported
- 1
- Injuries reported
- 96
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 534 adverse event reports that list this exact device (DI 04035479136314), received between Jun 25, 2018 and Sep 30, 2026 — classified as 1 death, 96 injuries, 437 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (384 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 Indicator384
- Adverse Event Without Identified Device or Use Problem70
- Premature End-of-Life Indicator55
- Failure to Interrogate16
- Battery Problem8
- Inappropriate/Inadequate Shock/Stimulation6
- Ambient Noise Problem3
- Device Sensing Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions441
- Unspecified Infection60
- No Known Impact Or Consequence To Patient19
- Shock from Patient Lead(s)4
- Discomfort2
- Implant Pain2
- Pain2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 534 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Premature Elective Replacement Indicator; Battery Problem
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 50946778 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50926789 ↗InjurySep 28, 2026Premature Elective Replacement Indicator; Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926658 ↗MalfunctionSep 15, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779247 ↗InjurySep 8, 2026Premature Elective Replacement Indicator; Battery Problem
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 50671781 ↗InjuryAug 13, 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 50236454 ↗InjuryAug 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 50217233 ↗InjuryAug 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 50217230 ↗InjuryAug 7, 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 50180237 ↗InjuryAug 5, 2026Inappropriate/Inadequate Shock/Stimulation
Patient reported to the FDA that during a trip to the Philippines he received inappropriate shocks from this device and the attached lead. After being admitted to several different hospitals it was determined that the patient received 30-50 shocks and the device and lead needed to be replaced. This device was explanted and the associated RV lead was capped. This information was taken from MW5190114.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50146893 ↗InjuryJul 1, 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 25681953 ↗InjuryJun 8, 2026Inappropriate/Inadequate Shock/Stimulation
ONSET AND STABILITY WERE MET IN AN ATRIALLY-DRIVEN EPISODE AND INAPPROPRIATE SHOCK THERAPY WAS DELIVERED. THE DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25427819 ↗MalfunctionJun 4, 2026Battery Problem
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 25393111 ↗InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
THIS DEVICE WAS EXPLANTED DUE TO PATIENT COMPLAINT OF PAIN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Implant Pain
MAUDE report 25354127 ↗InjuryMay 26, 2026Premature 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 25293656 ↗InjuryMay 7, 2026Premature 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 25112351 ↗InjuryApr 29, 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 25036192 ↗InjuryApr 23, 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 24973588 ↗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 24867848 ↗InjuryMar 26, 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 24707734 ↗MalfunctionMar 23, 2026Premature Elective Replacement Indicator
DEVICE IS AT ERI WITH UNUSUAL 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 24662789 ↗InjuryMar 13, 2026Premature 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 24594759 ↗InjuryMar 3, 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 24501159 ↗InjuryFeb 23, 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 24413650 ↗InjuryFeb 12, 2026Premature 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 24326941 ↗
Other Implantable cardioverter defibrillator (non-CRT) devices
- EMBLEM™ MRI S-ICD A219Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 recalls36 deaths15,404 reports
- EMBLEM™ S-ICD A209Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall7 deaths6,788 reports
- EMBLEM™ S-ICD 3501Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)7 deaths4,936 reports
- Cobalt™ XT DR MRI SureScan™ DDPA2D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)3 recalls30 deaths1,603 reports
- ENDOTAK RELIANCE® G 0185Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,632 reports
- VIGILANT™ EL ICD DR D233Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,563 reports
- Evera MRI™ XT DR SureScan® DDMB1D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)1 recall35 deaths1,426 reports
- Durata™ 7122St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)27 deaths1,377 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