Epyra 8 DR-T 394930Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04035479131814), received between Jul 22, 2019 and Jun 22, 2022 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Capture” (2 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
- Failure to Capture2
- Adverse Event Without Identified Device or Use Problem1
- Premature Elective Replacement Indicator1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 22, 2022Failure to Capture; Failure to Capture
AFTER AN IMPLANTATION PERIOD OF APPROX. 66 MONTHS, A LOSS OF CAPTURE ON THE VENTRICULAR CHANNEL WAS OBSERVED. THE PATIENT WAS HOSPITALIZED. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14783046 ↗MalfunctionNov 18, 2020Failure to Capture; Failure to Capture
DEVICE WAS EXPLANTED DUE TO LOSS OF CAPTURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10864585 ↗MalfunctionOct 1, 2020Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
AFTER AN IMPLANTATION PERIOD OF APPROX. 58 MONTHS, IT WAS REPORTED THAT THE DEVICE SHOWS THE ERI STATUS. THE PATIENT WAS HOSPITALIZED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10612301 ↗InjuryJul 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO POCKET INFECTION.
Patient problems: Unspecified Infection
MAUDE report 8814004 ↗
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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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