Protego S 75 379968Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04035479121471), received between Sep 1, 2022 and Aug 14, 2024 — classified as 2 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Ambient Noise Problem1
- Fracture1
- High impedance1
- Impedance Problem1
- Over-Sensing1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2024Over-Sensing; Ambient Noise Problem; Impedance Problem; Over-Sensing; Ambient Noise Problem; Impedance Problem
THIS LEAD SHOWS NOISE ON THE NEAR FIELD AS WELL AS OOR IMPEDANCE ON BOTH PACING AND SHOCK. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19983191 ↗MalfunctionSep 1, 2022Fracture; High impedance; Fracture; High impedance
THIS LEAD WAS EXPLANTED DUE TO HIGH IMPEDANCE AND FRACTURE. 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 15335034 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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