Intica 7 VR-T DX DF-1 ProMRI 404633Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Intica 7 defibrillator is an implanted device that corrects abnormal heart rhythms. Most of the 314 reports describe the battery warning appearing earlier than expected, and some describe devices removed from patients because of unexpected battery behavior. There were 88 injury reports and no deaths, and no recalls name this device. Reports fell to 30 in the latest 12 months from 59 in the 12 months 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
- 315
- Deaths reported
- 0
- Injuries reported
- 88
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 315 adverse event reports that list this exact device (DI 04035479142209), received between Jun 29, 2018 and Sep 29, 2026 — classified as 88 injuries, 227 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (205 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 Indicator205
- Adverse Event Without Identified Device or Use Problem69
- Premature End-of-Life Indicator24
- Battery Problem8
- Failure to Interrogate7
- Defibrillation/Stimulation Problem2
- Inappropriate/Inadequate Shock/Stimulation2
- Unexpected Mode Switch2
Patient problems
- No Clinical Signs, Symptoms or Conditions234
- Unspecified Infection59
- No Known Impact Or Consequence To Patient10
- Pocket Erosion7
- Hematoma4
- Pain2
- Twiddlers Syndrome2
- Discomfort1
Recent adverse event reports
The 25 most recent of 315 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Premature Elective Replacement Indicator; Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932648 ↗InjurySep 28, 2026Premature Elective Replacement Indicator; Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926660 ↗InjurySep 23, 2026Premature 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 50868925 ↗InjuryMay 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 25148593 ↗InjuryApr 22, 2026Premature 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 24960294 ↗MalfunctionApr 20, 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 24932920 ↗InjuryApr 8, 2026Premature Elective Replacement Indicator
THIS DEVICE WAS EXPLANTED DUE TO ERI WITH UNEXPECTED BATTERY BEHAVIOR. NO OTHER 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 24822173 ↗InjuryMar 30, 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 24720519 ↗InjuryMar 24, 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 24676084 ↗InjuryMar 23, 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 24662325 ↗InjuryMar 2, 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 24484713 ↗InjuryFeb 23, 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 24415749 ↗InjuryFeb 23, 2026Premature End-of-Life Indicator; Inappropriate/Inadequate Shock/Stimulation
DEVICE EXPLANTED DUE TO EOS. PATIENT RECEIVED MULTIPLE SHOCKS DUE TO NOISE ON RV WHILE IN BACKUP MODE, RESULTING IN EOS. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24413649 ↗MalfunctionFeb 11, 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 24313238 ↗InjuryFeb 4, 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 24260932 ↗InjuryJan 29, 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 24209070 ↗MalfunctionJan 16, 2026Premature Elective Replacement Indicator
DEVICE SHOWS ERI WITH UNEXPECTED BATTERY BEHAVIOR. DEVICE SHOWED 50 PERCENT BATTERY AT JULY 2025 CHECK. 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 24099508 ↗MalfunctionJan 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 24041613 ↗MalfunctionJan 6, 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 23974584 ↗InjuryJan 5, 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 23956683 ↗MalfunctionDec 29, 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 23910893 ↗MalfunctionDec 22, 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 23871878 ↗MalfunctionDec 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 23811538 ↗MalfunctionDec 8, 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 23751432 ↗InjuryNov 20, 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 23611983 ↗
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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