Plexa ProMRI S 75Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04035479140038), received between Jan 29, 2019 and Sep 8, 2026 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Ambient Noise Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Ambient Noise Problem2
- Inappropriate/Inadequate Shock/Stimulation2
- High impedance1
- Over-Sensing1
- Under-Sensing1
Patient problems
- No Known Impact Or Consequence To Patient2
- Shock from Patient Lead(s)2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2026Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
This lead was capped due to noise resulting in inappropriate shock. Should additional information be received this file will be updated.
Patient problems: Shock from Patient Lead(s)
MAUDE report 50671091 ↗InjuryMar 25, 2025Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
THIS LEAD WAS CAPPED DUE TO NOISE AND INAPPROPRIATE SHOCKS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 21688123 ↗MalfunctionDec 23, 2021Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THIS LEAD WAS EXPLANTED AND REPLACED DUE TO OVERSENSING APPROX. 31 MONTHS AFTER THE IMPLANTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13078106 ↗MalfunctionFeb 6, 2020High impedance; High impedance
THIS LEAD WAS EXPLANTED DUE TO HIGH SHOCK IMPEDANCE. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9679430 ↗MalfunctionJan 29, 2019Under-Sensing; Under-Sensing
THIS LEAD WAS REPOSITIONED DUE TO UNDERSENSING. NO ADVERSE PATIENT EVENTS WERE REPORTED. THE LEAD REMAINS ACTIVELY IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8285920 ↗
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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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