Sentus ProMRI OTW QP S-95 401181Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04035479138424), received between Jan 6, 2022 and Jan 6, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Ambient Noise 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
- Ambient Noise Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2022Ambient Noise Problem; Ambient Noise Problem
ON (B)(6) 2021 IN ROUTINE FOLLOW UP, NOISES WERE OBSERVED ON THE RV LEAD AND THE LV LEAD ON IEMG. DEVICE IN RECALL GROUP. RV AND LV LEAD WILL BE REPLACED WITH THE ICD DUE TO RECALL, STATUS IS CURRENTLY UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13180093 ↗
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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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