Ilesto 7 VR-T DF4 US 383580Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04035479125363), received between Nov 19, 2018 and Jan 16, 2025 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (10 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 Indicator10
- Premature End-of-Life Indicator5
- Battery Problem1
- Failure to Interrogate1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator
THIS DEVICE IS AT EOS INDICATION WITH UNEXPECTED BATTERY BEHAVIOR. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21174389 ↗MalfunctionJun 19, 2024Failure to Interrogate; Premature End-of-Life Indicator; Failure to Interrogate; Premature End-of-Life Indicator
DEVICE EXPLANTED DUE TO EOS INDICATION WITH UNEXPECTED BATTERY BEHAVIOR AND UNABLE TO INTERROGATE. 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 19569750 ↗MalfunctionMay 20, 2024Premature End-of-Life Indicator; Premature 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 19354764 ↗MalfunctionOct 2, 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 17856899 ↗MalfunctionFeb 15, 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 16378274 ↗MalfunctionFeb 15, 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 16378255 ↗MalfunctionSep 15, 2022Premature 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 15433364 ↗MalfunctionSep 13, 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. PLEASE NOTE THIS ICD IS AFFECTED BY A FIELD SAFETY CORRECTIVE ACTION, BIO-LQC, INITIATED IN MARCH 2021.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15412815 ↗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 13395745 ↗MalfunctionOct 5, 2021Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE EXPLANTED DUE TO EOS. 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 12579833 ↗MalfunctionSep 27, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED. PREMATURE ERI STATUS TRIPPED ON HOME MONITORING, DUE TO RECOMMENDATIONS AND THE DEVICE BEING ON THE AFFECTED LIST, IT WAS REPLACED. 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 12533029 ↗MalfunctionSep 23, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
HOME MONITORING DETECTED ERI ON (B)(6) 2021. BATTERY WAS MEASURED AT 62 PERCENT ON (B)(6) 2020. DEVICE WAS EXPLANTED ON (B)(6) 2021 DUE TO ERI WITH PREMATURE BATTERY DEPLETION AND RETURNED FOR ANALYSIS. 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 12518362 ↗MalfunctionSep 17, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE REMAINS IMPLANTED. (B)(6) REPORTED UNEXPECTED ERI ON (B)(6) 2021. ON (B)(6) 2021. (B)(6) REPORTED 54 PERCENT BATTERY. 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 12492705 ↗MalfunctionJul 28, 2021Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE WENT FROM ERI A WEEK AGO, TO EOS DAY OF EXPLANT. 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 12243092 ↗MalfunctionMar 26, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE WENT FROM 59 PERCENT TO ERI OVERNIGHT. 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 11575149 ↗MalfunctionNov 19, 2018Battery Problem; Battery Problem
THIS DEVICE ALERTED ERI VIA HOME MONITORING ON (B)(6) 2018. AN ANALYSIS OF THE DEVICE DATA INDICATED THAT THE DEVICE SHOULD BE REPLACED. IT WAS EXPLANTED AND REPLACED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8084573 ↗
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