Plexa ProMRIRecalls & reported problems across all models
BIOTRONIK SE & Co. KG · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3,710
- Deaths reported
- 10
- Injuries reported
- 1,570
- Recalls
- 0
We found 9 models of Plexa ProMRI by BIOTRONIK SE & Co. KG in the FDA's device registry (GUDID). Together they are named in 3,710 adverse event reports in the FDA's MAUDE database, received between Jun 14, 2018 and Sep 30, 2026 — classified as 10 deaths, 1,570 injuries, 2,130 malfunctions.
The most frequently reported specific device problem is “Ambient Noise Problem” (1,096 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Plexa ProMRI problems
Device problems
- Ambient Noise Problem1,096
- Adverse Event Without Identified Device or Use Problem1,045
- Device Dislodged or Dislocated473
- Over-Sensing415
- Inappropriate/Inadequate Shock/Stimulation376
- High impedance298
- Fracture274
- High Capture Threshold160
Patient problems
- No Clinical Signs, Symptoms or Conditions1,764
- Unspecified Infection879
- No Known Impact Or Consequence To Patient403
- Shock from Patient Lead(s)374
- Twiddlers Syndrome73
- Cardiac Perforation48
- Pocket Erosion42
- Ventricular Fibrillation25
Plexa ProMRI models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Plexa ProMRI S 65Permanent defibrillator electrodes9 deaths1,592 reports
- Plexa ProMRI S DX 65/15Permanent defibrillator electrodes1 death762 reports
- Plexa ProMRI DF-1 S DX 65/15Permanent defibrillator electrodes652 reports
- Plexa ProMRI SD 65/18Permanent defibrillator electrodes294 reports
- Plexa ProMRI S DX 65/17Permanent defibrillator electrodes197 reports
- Plexa ProMRI DF-1 S DX 65/17Permanent defibrillator electrodes175 reports
- Plexa ProMRI DF-1 SD 65/18Permanent defibrillator electrodes32 reports
- Plexa ProMRI S 75Permanent defibrillator electrodes5 reports
- Plexa ProMRI SD 75/18Permanent defibrillator electrodes1 report
Recent Plexa ProMRI adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Ambient Noise Problem; Device Sensing Problem; Unstable Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955015 ↗MalfunctionSep 30, 2026Ambient Noise Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954937 ↗InjurySep 29, 2026Fracture; Ambient Noise Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940688 ↗MalfunctionSep 29, 2026Ambient Noise Problem
HMSC reported recordings showing noise which resulted in VF detections. RV short interval counter increased >249. All other lead trends appear stable. Lead currently remains implanted. No adverse patient events were reported. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932652 ↗InjurySep 29, 2026Fracture; Ambient Noise Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932650 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50926790 ↗MalfunctionSep 25, 2026Ambient Noise Problem
RV lead noise was reported. Lead is currently implanted. No adverse patient events were reported. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899519 ↗InjurySep 25, 2026Fracture; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
This lead was explanted due to fracture resulting in noise and inappropriate shocks. Should additional information be received this file will be updated.
Patient problems: Shock from Patient Lead(s)
MAUDE report 50899335 ↗InjurySep 25, 2026Ambient Noise Problem
Lead was explanted due to Noise. No adverse patient events were reported. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898907 ↗InjurySep 24, 2026Ambient Noise Problem
This lead was capped due to noise. No adverse patient events were reported. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889995 ↗InjurySep 24, 2026Impedance Problem
This lead was explanted due to unstable pacing impedance. No adverse patient events were reported. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886246 ↗InjurySep 16, 2026Impedance Problem
This lead was explanted due to increasing impedance over time. No adverse patient events were reported. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787689 ↗MalfunctionSep 16, 2026Ambient Noise Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787588 ↗InjurySep 16, 2026Inappropriate/Inadequate Shock/Stimulation; Under-Sensing
This lead was explanted due to failed shock and undersensing VF. Should additional information be received this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787437 ↗InjurySep 16, 2026Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
This RV lead was explanted due to noise resulting in multiple inappropriate shocks. Should additional information be received, this file will be updated.
Patient problems: Shock from Patient Lead(s)
MAUDE report 50783490 ↗
Other BIOTRONIK SE & Co. KG products
All BIOTRONIK SE & Co. KG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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