Iperia 7 VR-T DX DF-1 ProMRI 393032Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Iperia 7 defibrillator has 375 reports, with no deaths and 50 injuries. Most describe battery-replacement warnings coming earlier than expected, sometimes followed by removal of the device, and a smaller number mention ineffective shocks, lead problems and infections. No recalls name this device. Recent reports fell from 37 to 17 compared with the period before.
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
- 374
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 374 adverse event reports that list this exact device (DI 04035479129477), received between Jun 14, 2018 and Sep 28, 2026 — classified as 48 injuries, 326 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (266 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 Indicator266
- Premature End-of-Life Indicator52
- Adverse Event Without Identified Device or Use Problem39
- Failure to Interrogate14
- Battery Problem11
- Inappropriate/Inadequate Shock/Stimulation3
- Fracture2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions316
- Unspecified Infection34
- No Known Impact Or Consequence To Patient17
- Drug Resistant Bacterial Infection1
- Implant Pain1
- Loss of consciousness1
- Pain1
- Pocket Erosion1
Recent adverse event reports
The 25 most recent of 374 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Premature End-of-Life Indicator; Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926702 ↗MalfunctionAug 25, 2026Failure to Transmit Record; Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50439688 ↗InjuryMay 7, 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 25112040 ↗InjuryApr 13, 2026Premature End-of-Life Indicator
DEVICE IS AT EOS 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 24860707 ↗InjuryApr 8, 2026Inappropriate/Inadequate Shock/Stimulation
THIS ICD WENT ERI ON (B)(6) 2026 WHEN THERE WERE MULTIPLE INEFFECTIVE SHOCKS. PER PROGRAMMER REPORT, THERE WAS LEAD NOISE, ABORTED SHOCKS DUE TO SHOCK IMPEDANCE LESS THAN 20 OHMS, AND PACING IMPEDANCE LESS THAN 200 OHMS. APPEARS TO BE LEAD INTEGRITY ISSUE AND 74 SHOCKS DELIVERED ON (B)(6) 2026. PATIENT WAS FOUND UNRESPONSIVE. SYSTEM REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Loss of consciousness
MAUDE report 24823178 ↗InjuryMar 23, 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 24664906 ↗InjuryMar 12, 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 24584957 ↗InjuryMar 11, 2026Premature End-of-Life Indicator
THIS DEVICE WAS EXPLANTED DUE TO EOS AFTER DELIVERING 26 INAPPROPRIATE SHOCKS DUE TO NOISE ON THE RV LEAD. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24574561 ↗MalfunctionFeb 26, 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 24463298 ↗MalfunctionFeb 19, 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 24391122 ↗InjuryFeb 12, 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 24322424 ↗InjuryJan 19, 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 24110615 ↗MalfunctionJan 5, 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 23967555 ↗MalfunctionNov 24, 2025Premature End-of-Life Indicator; Premature Elective Replacement Indicator; Premature 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 23636523 ↗MalfunctionNov 17, 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 23575265 ↗MalfunctionNov 17, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE SHOWED EOS ON (B)(6) 2025. PATIENT REFUSED HOME MONITORING. IN OFFICE CHECK 6 MONTHS PRIOR SHOWED 14 PERCENT BATTERY REMAINING. 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 23568946 ↗MalfunctionAug 27, 2025Failure to Interrogate; Premature End-of-Life Indicator; Failure to Interrogate; Premature End-of-Life Indicator
DEVICE IS AT EOS INDICATION WITH UNEXPECTED BATTERY BEHAVIOR AND COULD NOT BE INTERROGATED. 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 22902808 ↗MalfunctionAug 25, 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 22884739 ↗MalfunctionAug 18, 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 22835255 ↗MalfunctionAug 11, 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 22779007 ↗MalfunctionJul 30, 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 22665349 ↗MalfunctionJul 15, 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 22508607 ↗MalfunctionJul 15, 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 22508596 ↗MalfunctionJul 15, 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 22508437 ↗MalfunctionJun 30, 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 22366863 ↗
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.
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