Lumax 740 VR-T 365609Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04035479110284), received between Apr 25, 2019 and May 12, 2022 — classified as 2 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Premature End-of-Life Indicator” (6 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 Indicator6
- Battery Problem2
- Adverse Event Without Identified Device or Use Problem1
- Ambient Noise Problem1
- Inappropriate/Inadequate Shock/Stimulation1
- Premature Elective Replacement Indicator1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Known Impact Or Consequence To Patient4
- Sepsis1
- Shock from Patient Lead(s)1
- Unspecified Infection1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryMay 12, 2022Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
THIS DEVICE WAS EXPLANTED DUE TO REPORTED NOISE AND INAPPROPRIATE SHOCKS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 14380244 ↗MalfunctionApr 18, 2022Premature End-of-Life Indicator; Premature End-of-Life Indicator
IT WAS REPORTED THAT THE DEVICE WENT FROM 39 PERCENT BATTERY REMAINING, TO ERI IN ONE DAY, AND THEN TO EOS A FEW HOURS LATER ON HOME MONITORING. DEVICE CURRENTLY 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 14137867 ↗MalfunctionMar 30, 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 13953839 ↗InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO INFECTION AND SEPSIS. NEW SYSTEM WAS IMPLANTED (B)(6) 2021. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Sepsis; Unspecified Infection
MAUDE report 12828517 ↗MalfunctionJun 16, 2021Premature End-of-Life Indicator; Premature End-of-Life Indicator
AFTER AN IMPLANTATION PERIOD OF APPROX. 99 MONTHS, IT WAS REPORTED THAT THE DEVICE SHOWS THE EOS STATUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12013568 ↗MalfunctionOct 13, 2020Battery Problem; Battery Problem
ON (B)(6) 2019 IT WAS REPORTED THAT ON (B)(6) 2019, 2019 THE BATTERY WAS AT 57 PERCENT AND ON (B)(6) 2019 THE DEVICE WAS AT ERI PER HOME MONITORING. THE PATIENT WAS BROUGHT IN FOR A DEVICE CHECK AND THE DEVICE WAS NOT SHOWING AT ERI. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2019.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10673552 ↗MalfunctionOct 8, 2020Battery Problem; Battery Problem
IT WAS REPORTED THAT THIS DEVICE DETECTED ERI ON (B)(6) 2019. DEVICE EVALUATION REVEALED A BATTERY ISSUE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10649616 ↗MalfunctionJan 15, 2020Premature End-of-Life Indicator; Premature End-of-Life Indicator
IT WAS REPORTED THAT THIS DEVICE HAD TRIGGERED EOS IN (B)(6) 2017. THE PATIENT REPORTED NEVER HAVING RECEIVED THERAPY. DEVICE REMAINS IMPLANTED BUT WILL BE CHANGED OUT IN THE FUTURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9593273 ↗MalfunctionOct 22, 2019Premature End-of-Life Indicator; Premature End-of-Life Indicator
AFTER AN IMPLANTATION PERIOD OF APPROX. 76 MONTHS, IT WAS REPORTED THAT THE DEVICE SHOWED EOS STATUS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9221571 ↗MalfunctionSep 26, 2019Premature End-of-Life Indicator; Premature End-of-Life Indicator
THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO EOS. BATTERY DEPLETION WAS CAUSED BY A LEAD FRACTURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9126349 ↗MalfunctionApr 25, 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. BASED ON THE DEVICE ANALYSIS, THIS IS REPORTABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8552630 ↗
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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