Entovis DR-T 365463Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04035479109790), received between Mar 29, 2019 and Jul 7, 2021 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Battery Problem” (1 report).
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 Problem2
- Battery Problem1
Patient problems
- Unspecified Infection2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 7, 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.
Patient problems: Unspecified Infection
MAUDE report 12129988 ↗MalfunctionJul 11, 2019Battery Problem; Battery Problem
ON (B)(6) 2019, A MESSAGE OF BATTERY ERROR DETECTED PERFORM A MEMORY DUMP AND CONTACT BIOTRONIK - WAS DISPLAYED ON THE PROGRAMMER SCREEN AND A RAM DUMP WAS PERFORMED. BATTERY INFORMATION SHOWED 25 PERCENT AND 1 YEAR 11 MONTHS, THOUGH IN THE LAST FOLLOW UP (B)(6) 2019) IT SHOWED 50 PERCENT AND 5 YEARS 11 MONTHS. OUTPUT SETTING WAS CHANGED SEVERAL TIMES AND FINALLY THE SETTING WAS SET AT 2.4 V ON BOTH THE A AND V CHANNEL. THE DEVICE APPEARS TO REMAIN IMPLANTED AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8782918 ↗InjuryMar 29, 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 8465349 ↗
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- Edora 8 DR-T 407145BIOTRONIK SE & Co. KG · Pulse generator, permanent, implantable10 deaths982 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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