Lumax 740 VR-T DX 372419Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04035479116057), received between Jul 11, 2018 and Jun 27, 2022 — classified as 5 injuries, 17 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 Problem3
- Battery Problem3
- Premature Elective Replacement Indicator3
- Device Dislodged or Dislocated1
- Failure to Convert Rhythm1
- Inappropriate/Inadequate Shock/Stimulation1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Known Impact Or Consequence To Patient5
- Unspecified Infection2
- Endocarditis1
- Shock from Patient Lead(s)1
- Twiddlers Syndrome1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2022Premature End-of-Life Indicator; Premature End-of-Life Indicator
AFTER AN IMPLANTATION PERIOD OF APPROX. 105 MONTHS, IT WAS OBSERVED THAT THE DEVICE SHOWS THE EOS STATUS. THE ICD WAS EXPLANTED. 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 14837214 ↗MalfunctionJun 13, 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 14681452 ↗MalfunctionApr 11, 2022Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE AT (B)(4). HOME MONITORING SHOWED 38 PERCENT BATTERY ON (B)(6) 2022. PATIENT WILL BE BROUGHT IN FOR A FOLLOW UP. 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 14079509 ↗MalfunctionFeb 22, 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 13578053 ↗MalfunctionNov 9, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE WAS EOS ON HOME MONITORING, WHEN PREVIOUS TRANSMISSION WAS 9 PERCENT. 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 12780116 ↗MalfunctionSep 8, 2021Premature 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 12438141 ↗InjuryAug 12, 2021Sparking; Noise, Audible; Sparking; Noise, Audible
DEVICE REMAINS IMPLANTED. IT WAS REPORTED THAT PATIENT AND PATIENTS WIFE OBSERVED A SPARK ABOVE THE DEVICE AND HEARD A POPPING SOUND WHEN APPROPRIATE SHOCK THERAPY WAS DELIVERED. DEVICE CHECK WAS RECOMMENDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12314396 ↗MalfunctionJun 10, 2021Premature End-of-Life Indicator; Premature End-of-Life Indicator
AFTER AN IMPLANTATION PERIOD OF APPROX. 95 MONTHS, IT WAS REPORTED THAT THE DEVICE SHOWS THE EOS STATUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11980203 ↗InjuryJun 8, 2021Adverse 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 11960406 ↗InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO ENDOCARDITIS. NEW SYSTEM WAS NOT IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Endocarditis
MAUDE report 11776963 ↗MalfunctionMar 19, 2021Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE EXPLANTED DUE TO REACHING EOS ON (B)(6) 2021. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE. ON 17-MAR-2021 DEVICE RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11529198 ↗MalfunctionMar 15, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
IT WAS REPORTED THAT THIS DEVICE REACHED ERI ON HOME MONITORING AS OF (B)(6) 2020, BUT THE DEVICE EXITED THE ERI STATE AND IS NOW AT MOL1 WITH 49 PERCENT BATTERY REMAINING. DATA ANALYSIS REVEALED A BATTERY ISSUE. 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 11489728 ↗MalfunctionMar 10, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
IT WAS REPORTED THAT THIS DEVICE TRIPPED ERI IN (B)(6) OF 2020 AFTER HAVING 60 PERCENT BATTERY REMAINING ONE MONTH PRIOR. THE DEVICE WAS EXPLANTED ON (B)(6) 2020. THE MANUFACTURERS ANALYSIS REVEALED A BATTERY ISSUE. 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 11453958 ↗MalfunctionOct 8, 2020Battery Problem; Battery Problem
IT WAS REPORTED THAT THIS DEVICE DETECTED ERI ON (B)(6) 2019. DEVICE WAS EXPLANTED AND REPLACED. THE 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 10649648 ↗MalfunctionAug 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
SYSTEM EXPLANTED DUE TO DISLODGEMENT CAUSED BY TWIDDLER SYNDROME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Twiddlers Syndrome
MAUDE report 10387144 ↗MalfunctionApr 2, 2020Failure to Convert Rhythm; Failure to Convert Rhythm
DEVICE DID NOT RESCUE AT 40 J DOCUMENTED. PHYSICIAN DECIDED ON HIGH ENERGY DEVICE AND INSERTION OF FLOATING MDT COIL IN THE AZYGOS VEIN. DFT SUCCESSFUL WITH NEW SYSTEM. THE CAUSE OF FAILED RESCUE MIGHT HAVE BEEN EXTERNAL FACTORS, DUE TO EXTREME CARDIOMYOPATHY AND OR LEAD SLACK PULLED BACK SLIGHTLY UPON REVIEW OF X RAY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9915509 ↗MalfunctionMar 5, 2020Battery Problem; Battery Problem
THIS DEVICE WAS EXPLANTED ON (B)(6) 2019 DUE TO ERI. THE MANUFACTURERS ANALYSIS REVEALED A BATTERY ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9793146 ↗MalfunctionDec 11, 2019Battery Problem; Battery Problem
THIS DEVICE WAS EXPLANTED DUE TO ERI. BASED ON THE MANUFACTURERS ANALYSIS RESULTS RECEIVED ON 2-DEC-2019, THIS EVENT IS REPORTABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9450570 ↗InjuryNov 19, 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 SINGLE-CHAMBER ICD SYSTEM WAS IMPLANTED ON THE SAME DAY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 9342612 ↗MalfunctionAug 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
UPON INTERROGATION THE ICD THERAPY FOR THE PATIENT WAS DISABLED. THE LAST INTERROGATION RECORD THE OFFICE HAD MATCHED THE LAST FOLLOWUP DATE ON THE PROGRAMMER, AND THERAPY WAS ENABLED. THE OFFICE DID NOT HAVE A REASON WHY THE ICD THERAPY WOULD BE PROGRAMMED OFF. PATIENT DID NOT REPORT ANY SURGERIES OR RADIATION THERAPY. RAM DUMP RECEIVED FOR ANALYSIS. DEVICE REMAINS IMPLANTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8884510 ↗InjuryAug 8, 2019Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
PATIENTS DEVICE WAS REPROGRAMMED AT SOME POINT IN THE LAST 2 YEARS TO HAVE A THERAPY ZONE AT 125 BPM INSTEAD OF THE PREVIOUSLY PROGRAMMED 188 BPM ZONE. THE PATIENT REPORTEDLY RECEIVED INAPPROPRIATE SHOCKS IN THIS ZONE (B)(6) 2019 POSSIBLY DUE TO THE LOW 125 BPM. THE OFFICE DOES NOT HAVE ADEQUATE PATIENT RECORDS AND CANNOT IDENTIFY WHEN THE PROGRAMMING CHANGE WAS MADE. DEVICE REMAINS IMPLANTED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 8876698 ↗MalfunctionJul 11, 2018Premature End-of-Life Indicator; Premature End-of-Life Indicator
ON (B)(6) 2018 THE DEVICE SHOWED EOS. THE DEVICE WAS AT 78% REMAINING ON (B)(6) 2017. THE PATIENT IS NOT FOLLOWED ON HOME MONITORING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7678817 ↗
Other Implantable cardioverter defibrillator (non-CRT) devices
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- 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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