Lumax 740 HF-T 365608Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04035479110277), received between Apr 23, 2019 and Jun 27, 2022 — classified as 1 injury, 9 malfunctions.
The most frequently reported specific device problem is “Premature End-of-Life Indicator” (8 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
- Premature End-of-Life Indicator8
- Adverse Event Without Identified Device or Use Problem1
- Battery Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Known Impact Or Consequence To Patient2
- Unspecified Infection1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2022Premature End-of-Life Indicator; Premature End-of-Life Indicator
THIS DEVICE SHOWS EOS ON HOME MONITORING. 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 14830659 ↗MalfunctionMay 20, 2022Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE EOS. EXPLANT PROCEDURE IS PLANNED AND DEVICE REMAINS ACTIVELY IMPLANTED AT THIS TIME. 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 14462308 ↗MalfunctionMar 15, 2022Premature 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 13765103 ↗MalfunctionJan 20, 2022Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE IS AT EOS INDICATION AND WAS EXPLANTED AND REPLACED. 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 13307145 ↗MalfunctionJan 13, 2022Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE IS AT EOS INDICATION AND WAS EXPLANTED AND REPLACED. 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 13251297 ↗MalfunctionJul 15, 2021Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE REMAINS IMPLANTED. BATTERY WENT FROM 8 PERCENT TO EOS IN ONE DAY. NURSE PRACTITIONER SAID THAT DEVICE WILL BE EXPLANTED AND SENT BACK 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 12177551 ↗MalfunctionSep 17, 2020Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE WENT FROM 4 PERCENT BATTERY ON (B)(6) 2020 TO EOS ON (B)(6) 2020. 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 10551245 ↗MalfunctionFeb 12, 2020Battery Problem; Battery Problem
THIS DEVICE WAS EXPLANTED DUE TO ERI. THE MANUFACTURERS ANALYSIS REVEALED A BATTERY ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9699719 ↗MalfunctionJul 24, 2019Premature End-of-Life Indicator; Premature End-of-Life Indicator
THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO EOS STATUS. NO ADVERSE PATIENT EVENTS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8824069 ↗InjuryApr 23, 2019Adverse 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 8542338 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page