Lumax 740 DR-T 365606Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Lumax 740 DR-T is an implanted dual-chamber defibrillator. Its 47 reports mostly describe units reaching end of service or elective replacement earlier than expected, along with battery drain, shocks felt from the patient's leads, and monitoring or transmission problems. Reports mention 1 death and 12 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 47
- Deaths reported
- 1
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 04035479110253), received between Mar 19, 2019 and Feb 10, 2026 — classified as 1 death, 12 injuries, 34 malfunctions.
The most frequently reported specific device problem is “Premature End-of-Life Indicator” (25 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 End-of-Life Indicator25
- Adverse Event Without Identified Device or Use Problem9
- Battery Problem5
- Premature Elective Replacement Indicator3
- Communication or Transmission Problem2
- Failure to Interrogate2
- Inappropriate/Inadequate Shock/Stimulation2
- Interrogation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- No Known Impact Or Consequence To Patient14
- Unspecified Infection8
- Shock from Patient Lead(s)2
- Asystole1
- Death1
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
InjuryFeb 10, 2026Premature End-of-Life Indicator
DEVICE EXPLANTED DUE TO EOS. 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 24309594 ↗MalfunctionMay 19, 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 14435479 ↗MalfunctionMay 4, 2022Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE WENT TO ERI. BASED ON THE DEVICE ANALYSIS, THIS IS REPORTABLE. 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 14272811 ↗MalfunctionMar 24, 2022Premature End-of-Life Indicator; Premature End-of-Life Indicator
HOME MONITORING REPORTED DEVICE SHOWED 29 PERCENT BATTERY REMAINING (B)(6) 2022 THEN EOS ON (B)(6) 2022. 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 13890310 ↗MalfunctionMar 2, 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 13653621 ↗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 13578063 ↗MalfunctionFeb 10, 2022Battery Problem; Battery Problem
DEVICE WAS SHOWING ERI ON HOME MONITORING BUT NOT IN THE OFFICE AT FOLLOW UP IN (B)(6) 2020. BASED ON THE DEVICE ANALYSIS, THIS IS REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13508269 ↗MalfunctionNov 9, 2021Premature End-of-Life Indicator; Premature End-of-Life Indicator
AFTER AN IMPLANTATION PERIOD OF APPROX. 106 MONTHS, IT WAS REPORTED THAT THE DEVICE SHOWS THE EOS STATUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12780083 ↗MalfunctionOct 19, 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 12656255 ↗MalfunctionOct 5, 2021Premature End-of-Life Indicator; Premature End-of-Life Indicator
IT WAS REPORTED THAT THE DEVICE WENT FROM 9 PERCENT BATTERY REMAINING TO EOS IN ONE DAY 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 12579841 ↗MalfunctionSep 21, 2021Battery Problem; Battery Problem
THIS DEVICE WAS AT ERI INDICATION. THE DEVICE WAS EXPLANTED AND REPLACED. BASED ON THE ANALYSIS THIS IS REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12510037 ↗DeathSep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS DEVICE DIED SUDDENLY. THE ICD WAS REMOVED BY THE FUNERAL DIRECTORS USING A MAGNET TO INHIBIT SHOCKS. THE LEADS WERE CUT AND THE ICD WAS PLACED IN A METAL BOWL. THE DEVICE COULD NOT BE INTERROGATED AFTER THE EXPLANTATION. THE DEVICE AND THE ASSOCIATED LEADS WERE RETURNED AND ANALYZED.
Patient problems: Asystole
MAUDE report 12474660 ↗MalfunctionJul 6, 2021Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE REMAINS IMPLANTED. EOS ON HOME MONITORING (B)(6) 2021, AND HAD 29 PERCENT WITH 2.94V BATTERY ON REMOTE (B)(6) 2021. 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 12125292 ↗MalfunctionJun 11, 2021Premature End-of-Life Indicator; Premature End-of-Life Indicator
IT WAS REPORTED THAT THIS DEVICE WENT FROM 24 PERCENT BATTERY TO EOS. PATIENT REPORTED NO PROCEDURES OR MRIS. NO ADVERSE PATIENT EVENTS WERE REPORTED. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11983101 ↗InjuryMay 10, 2021Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE REMAINS IMPLANTED. PATIENT PRESENTED TO ER DUE TO INAPPROPRIATE SHOCKS. UPON INITIAL INTERROGATION, THE DEVICE WAS AT EOS. OVERSENSING WAS NOTED ON THE RV LEAD. NO DIAGNOSTIC INFORMATION OR PARAMETER SETTINGS WERE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11802736 ↗MalfunctionApr 26, 2021Premature End-of-Life Indicator; Premature End-of-Life Indicator
IT WAS REPORTED THAT THIS DEVICE DELIVERED A SERIES OF SHOCKS THAT CAUSED THE DEVICE TO REACH EOS. IN-OFFICE INTERROGATION SHOWED LEAD OVERSENSING. DUE TO EOS STATE, CLINIC WAS UNABLE TO RUN LEAD TESTING. PATIENT DEVICE HAS NOT BEEN CHECKED IN 3 YEARS. DEVICE AND LEADS REMAIN IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11729519 ↗InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 11710754 ↗InjuryMar 25, 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 11571050 ↗MalfunctionMar 24, 2021Premature End-of-Life Indicator; Premature End-of-Life Indicator
REPORTED DEVICE WENT FROM 53 PERCENT BATTERY REMAINING TO ERI ON (B)(6) 2021, FOLLOWED BY EOS ON (B)(6) 2021. NO TACHYCARDIA DETECTIONS OR THERAPIES WERE REPORTED IN THAT TIME. 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 11563470 ↗MalfunctionMar 4, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
IT WAS REPORTED THAT THIS DEVICE SHOWED ERI ON HMSC WEBSITE ON (B)(6) 2020. DEVICE WAS EXPLANTED. THE ANALYSIS RESULTS 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 11416551 ↗MalfunctionFeb 18, 2021Premature End-of-Life Indicator; Premature End-of-Life Indicator
AFTER AN IMPLANTATION PERIOD OF APPROX. 101 MONTHS, IT WAS OBSERVED VIA HOMEMONITORING THAT THE DEVICE SHOWS THE EOS STATUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11345951 ↗MalfunctionJan 18, 2021Failure to Interrogate; Failure to Interrogate
THE PHYSICIAN INDICATED THAT THIS DEVICE HAD A GOOD AMOUNT OF BATTERY LEFT AT LAST INTERROGATION, HOWEVER PRIOR TO A LEAD REVISION THE DEVICE IS UNABLE TO BE INTERROGATED. THIS DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11188785 ↗MalfunctionDec 29, 2020Premature End-of-Life Indicator; Premature End-of-Life Indicator
ERI WAS REPORTED IN (B)(6) 2018. THE PATIENT CAME IN FOR A CHANGE OUT AND IT WAS FOUND THAT THERE WAS 76 PERCENT BATTERY LEFT SO THE PATIENT WAS SENT HOME. THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO EOS ON (B)(6) 2020.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11088203 ↗MalfunctionDec 12, 2020Premature End-of-Life Indicator; Premature End-of-Life Indicator
EOS DETECTION ALERT WAS RECEIVED. APPROXIMATELY 20 PERCENT BATTERY REMAINED ON (B)(6)2020.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10996486 ↗InjuryAug 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 10417520 ↗
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- Ilesto 7 DR-T DF-1 US 383562BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER79 reports
- Ilivia 7 DR-T DF-1 ProMRI 404622BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER74 reports
- Ilivia Neo 7 DR-T DF-1 ProMRI 429529BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER1 death56 reports
- Itrevia 7 DR-T DF4 392426BIOTRONIK SE & Co. KG · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER1 death48 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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