Ilesto 7 HF-T DF-1 383547Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 1
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04035479125035), received between Sep 28, 2018 and May 18, 2022 — classified as 1 death, 9 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (3 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem9
- Premature Elective Replacement Indicator3
- Battery Problem1
- Difficult to Interrogate1
- Premature End-of-Life Indicator1
Patient problems
- Unspecified Infection5
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient2
- Pocket Erosion2
- Death1
- Endocarditis1
- Erosion1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2022Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE WAS CHANGED OUT DUE TO ERI ON (B)(6) 2021. BASED ON THE ANALYSIS REPORT WE WILL REPORT THIS TO FDA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14430925 ↗InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE EXPLANTED DUE TO EROSION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Pocket Erosion
MAUDE report 12721050 ↗InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE EXPLANTED DUE TO ENDOCARDITIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Endocarditis
MAUDE report 12433984 ↗MalfunctionMar 24, 2021Difficult to Interrogate; Difficult to Interrogate
DIFFICULTY ESTABLISHING A TELEMETRY SESSION WITH THE DEVICE. DEVICE HAS NOT TRANSMITTED TO HOME MONITORING SINCE (B)(6) 2019 WHERE IT SHOWED 62 PERCENT BATTERY REMAINING. DEVICE TO BE EVALUATED FURTHER AND CURRENTLY REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11563476 ↗MalfunctionNov 24, 2020Premature End-of-Life Indicator; Premature End-of-Life Indicator
THE DEVICE REACHED EOS AND WAS EXPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10891919 ↗InjuryMay 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. THERE IS CURRENTLY NO INDICATION THAT A NEW SYSTEM HAS BEEN IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 10025187 ↗InjuryMar 18, 2020Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THIS DEVICE WAS EXPLANTED AND REPLACED DURING A POCKET REVISION DUE TO EROSION. THE DEVICE WAS ALSO FOUND TO BE AT ERI. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion
MAUDE report 9849184 ↗DeathNov 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT IS DECEASED. PATIENTS FAMILY IS QUESTIONING THE FUNCTIONALITY OF THE DEVICE AT THE TIME OF DEATH. THE DEVICE IS CURRENTLY UNAVAILABLE FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Death
MAUDE report 9306711 ↗InjuryOct 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. A NEW SYSTEM WAS IMPLANTED ON (B)(6) 2019. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 9257908 ↗MalfunctionMay 22, 2019Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO ERI. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8633769 ↗InjuryJan 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO SPINAL INFECTION. THE PHYSICIAN DOES NOT BELIEVE THAT THE INFECTION WAS DEVICE RELATED. THERE IS CURRENTLY NO INDICATION THAT A NEW SYSTEM HAS BEEN IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 8286140 ↗InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO EROSION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Erosion
MAUDE report 8240078 ↗InjuryOct 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. NEW SYSTEM WAS NOT IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 7979690 ↗InjuryOct 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. NEW SYSTEM WAS IMPLANTED (B)(6) 2018. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 7927128 ↗MalfunctionSep 28, 2018Battery Problem; Battery Problem
ON (B)(6) 2014 - DURING A FOLLOW-UP, THERE WAS AN ERROR REPORTED OF ELEVATED POWER CONSUMPTION. A RESET WAS PERFORMED WITH NO ISSUES ALL THOUGH THE BATTERY STATUS CONTINUED TO DROP. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2018 DUE TO ERI.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7918766 ↗
Other Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) devices
- Gallant™ CDHFA500QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)2 recalls58 deaths8,401 reports
- Quartet™ 1458Q-86St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)207 deaths6,631 reports
- QUADRA ASSURA MP™ CD3369-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)103 deaths6,084 reports
- VIGILANT™ X4 CRT-D G247Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)17 deaths2,066 reports
- Quadra Assura™ CD3365-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)53 deaths2,056 reports
- Cobalt™ XT HF Quad CRT-D MRI SureScan™ DTPA2QQMedtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)4 recalls40 deaths1,639 reports
- Unify Assura™ CD3357-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)54 deaths1,784 reports
- Unify Assura™ CD3357-40CSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)56 deaths1,588 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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