Ilesto 7 DR-T DF4 US 383564Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BIOTRONIK Ilesto dual-chamber implantable defibrillator sits under the skin and helps keep the heart beating safely. Most reports describe units reaching the end of their service life sooner than expected, with unexpected battery behavior, so the device had to be taken out and replaced; a few mention infection or the device not being readable at a follow-up visit. There are 39 reports, 7 injuries and no deaths. No recalls name this device.
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
- 39
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 04035479125202), received between Oct 15, 2018 and Feb 9, 2026 — classified as 7 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (15 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 Indicator15
- Premature End-of-Life Indicator12
- Adverse Event Without Identified Device or Use Problem6
- Failure to Interrogate5
- Battery Problem2
- Failure to Convert Rhythm1
- No Pacing1
- Premature Discharge of Battery1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- Unspecified Infection6
- No Known Impact Or Consequence To Patient5
- Asystole1
- Ventricular Fibrillation1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
InjuryFeb 9, 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 24299898 ↗MalfunctionMay 27, 2025Premature 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 BE RECEIVED, THIS FILE WILL BE UPDATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22087435 ↗MalfunctionOct 7, 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 20392589 ↗MalfunctionAug 15, 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 19990016 ↗MalfunctionMar 18, 2024Premature End-of-Life Indicator; Premature End-of-Life Indicator
THIS DEVICE IS EOS. DEVICE REMAINS IMPLANTED. 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 18927124 ↗MalfunctionMar 14, 2024Premature 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 18903892 ↗InjuryNov 3, 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 18069768 ↗MalfunctionSep 7, 2023Premature 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 17698982 ↗MalfunctionJul 31, 2023Premature 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 17431084 ↗MalfunctionJun 26, 2023Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE EXPLANTED DUE TO EOL FROM MULTIPLE SHOCKS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17203959 ↗MalfunctionMay 31, 2023Premature 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 17035124 ↗MalfunctionMay 17, 2023Failure to Interrogate; Failure to Interrogate
THE PATIENT HAD AN LVAD IMPLANTED ON (B)(6) 2023. THE DEVICE COULD NOT BE INTERROGATED POST LVAD IMPLANT. THE DEVICE INTERROGATED NORMALLY PRIOR TO THE PROCEDURE. ALL TROUBLESHOOTING WAS UNSUCCESSFUL. THE PATIENT REMAINS HOSPITALIZED. DEVICE CURRENTLY REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16946307 ↗MalfunctionApr 17, 2023Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE WAS EXPLANTED DUE TO ERI 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 16755822 ↗MalfunctionOct 11, 2022Premature 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 15579202 ↗MalfunctionOct 3, 2022Premature 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 15527979 ↗MalfunctionJul 12, 2022Premature Elective Replacement Indicator; Premature 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 14986760 ↗InjuryFeb 2, 2022Adverse 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, IT WILL BE ADDED TO THIS FILE.
Patient problems: Unspecified Infection
MAUDE report 13430100 ↗MalfunctionJan 31, 2022Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE IS AT 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 13404090 ↗MalfunctionJan 12, 2022Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE AT EOS. PHYSICIAN DECIDED TO UPGRADE THE DEVICE. 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 13239973 ↗MalfunctionJan 4, 2022Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE AT ERI WITH UNEXPECTED BATTERY BEHAVIOR. NO ADVERSE PATIENT EVENTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13155081 ↗MalfunctionNov 11, 2021Failure to Interrogate; Failure to Interrogate
UNABLE TO INTERROGATE DEVICE. AT LAST FOLLOWUP IN (B)(6) 2021 THE BATTERY STATUS WAS 65 PERCENT. 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 12800667 ↗MalfunctionNov 9, 2021Failure to Interrogate; Failure to Convert Rhythm; No Pacing; Failure to Interrogate; Failure to Convert Rhythm; No Pacing
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE ER AFTER RECEIVING A SHOCK. A FIELD REPRESENTATIVE INTERROGATED THE DEVICE AT THE HOSPITAL AND DETERMINED THAT NO SHOCK HAD BEEN DELIVERED. THE DEVICE SHOWED 27 PERCENT BATTERY REMAINING, BUT COULD NOT BE INTERROGATED THE FOLLOWING DAY. PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE DEVICE WITH A COMPETITOR ICD. ON (B)(6) 2021, NEW INFORMATION WAS RECEIVED FROM A COMPETITOR INDICATING THAT THE PATIENT HAD EXPERIENCED VF AND ASYSTOLE, AND THE DEVICE DID NOT DELIVER SHOCKS OR PACING. DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Asystole; Ventricular Fibrillation
MAUDE report 12783331 ↗MalfunctionOct 28, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12710670 ↗MalfunctionSep 27, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12533039 ↗MalfunctionAug 25, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12368085 ↗
Other DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER devices
- Rivacor 7 DR-T DF4 ProMRI 429534BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER2 deaths286 reports
- Iperia 7 DR-T DF4 ProMRI 392423BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER3 deaths256 reports
- Ilivia 7 DR-T DF4 ProMRI 404623BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER2 deaths233 reports
- Iperia 7 DR-T DF-1 ProMRI 392409BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER93 reports
- Ilesto 7 DR-T DF-1 US 383562BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER79 reports
- Ilivia 7 DR-T DF-1 ProMRI 404622BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER74 reports
- Ilivia Neo 7 DR-T DF-1 ProMRI 429529BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER1 death56 reports
- Itrevia 7 DR-T DF4 392426BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER1 death48 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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