Etrinsa 8 SR-T 394936Recalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04035479131876), received between Apr 4, 2019 and Apr 27, 2022 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Interrogate” (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
- Failure to Interrogate1
- Premature Discharge of Battery1
Patient problems
- Arrhythmia1
- No Known Impact Or Consequence To Patient1
- Pocket Erosion1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE WAS EXPLANTED (B)(6) 2019 DUE TO EROSION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion
MAUDE report 14220058 ↗InjuryOct 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. EXPLANTING FACILITY COULD NOT LOCATE DATE OF EXPLANT. NEW DEVICE WAS IMPLANTED ON (B)(6) 2019. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 9244076 ↗MalfunctionAug 28, 2019Premature Discharge of Battery; Premature Discharge of Battery
PACEMAKER REACHED ERI DUE TO HIGH PACING THRESHOLD RESULTING IN DEVICE PROGRAMMED OUTPUT TO 7.0V AT 1.0MS. PATIENT IS 100 PERCENT PACED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8941103 ↗MalfunctionApr 4, 2019Failure to Interrogate; Failure to Interrogate
DEVICE WILL NOT INTERROGATE. PATIENT IS SHOWING PAUSES IN THE HEART RHYTHM VIA SURFACE ECG UNCHARACTERISTIC OF A PACEMAKER. IT IS SUSPECTED THAT THE DEVICE IS NO LONGER FUNCTIONING. THE DEVICE IS STILL IMPLANTED AT THIS TIME.
Patient problems: Arrhythmia
MAUDE report 8484545 ↗
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- Fortify Assura™ CD1357-40QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable35 deaths1,933 reports
- Ellipse™ CD2411-36QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable42 deaths1,498 reports
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- Accent® DR RFSt. Jude Medical, Inc. · Pulse generator, permanent, implantable73 deaths1,370 reports
- 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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