Plexa ProMRI DF-1Recalls & reported problems across all models
BIOTRONIK SE & Co. KG · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 67
- Deaths reported
- 2
- Injuries reported
- 22
- Recalls
- 0
We found 2 models of Plexa ProMRI DF-1 by BIOTRONIK SE & Co. KG in the FDA's device registry (GUDID). Together they are named in 67 adverse event reports in the FDA's MAUDE database, received between May 3, 2019 and Jun 30, 2026 — classified as 2 deaths, 22 injuries, 43 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (13 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 DF-1 problems
Device problems
- Adverse Event Without Identified Device or Use Problem17
- Over-Sensing13
- Device Dislodged or Dislocated9
- Ambient Noise Problem6
- Impedance Problem6
- High impedance5
- Break3
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- Unspecified Infection14
- No Known Impact Or Consequence To Patient7
- Shock from Patient Lead(s)2
- Cardiac Perforation1
- Cardiac Tamponade1
- Chest Pain1
- Death1
Plexa ProMRI DF-1 models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Plexa ProMRI DF-1 S 65Permanent defibrillator electrodes2 deaths65 reports
- Plexa ProMRI DF-1 S 75Permanent defibrillator electrodes2 reports
Recent Plexa ProMRI DF-1 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 25667269 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 24867756 ↗InjuryMar 10, 2026Device Dislodged or Dislocated
THIS LEAD WAS REPOSITIONED DUE TO DISLODGEMENT AND REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24564159 ↗MalfunctionFeb 23, 2026Impedance Problem
HMSC REPORTED SHOCK IMPEDANCE GRADUALLY INCREASING OVER THE PAST YEAR. ALL OTHER LEAD TRENDS WERE UNREMARKABLE. NO NOISE EVIDENT. ADVISED FURTHER LEAD EVALUATION. LEAD CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24420977 ↗InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 24249119 ↗MalfunctionNov 5, 2025Fracture; Fracture
THE P/S PORTION OF THIS LEAD WAS CAPPED DUE TO 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 23478441 ↗InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 23472100 ↗InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 22844226 ↗MalfunctionJul 21, 2025High impedance; High impedance
THIS LEAD WAS CAPPED DUE TO CHRONIC HIGH IMPEDANCE, >3000 OHMS. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22561347 ↗MalfunctionJul 15, 2025Break; Impedance Problem; Break; Impedance Problem
LEAD WAS EXPLANTED AND REPLACED BECAUSE OF OOR B COIL (RV) IMPEDANCE. UPON POCKET OPENING, THE RV COIL (DF1) SEGMENT WAS COMPLETELY SEPARATED FROM THE LEAD AT EXACTLY THE LEAD YOKE EXIT. THE LEAD SEGMENT APPEARED TO BE CUT. 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 22515585 ↗InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 21224652 ↗MalfunctionJan 13, 2025Device Sensing Problem; Device Sensing Problem
THE PACING PORTION OF THIS LEAD WAS CAPPED DUE TO NO SENSING WITH FINE VF. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21145493 ↗MalfunctionJan 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21113835 ↗InjuryJun 20, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
THIS RV LEAD WAS EXPLANTED AFTER FAILED ATTEMPT TO REPOSITION LEAD DUE TO HELIX WOULD NOT RETRACT. PATIENT HAD HAD A SYNCOPAL EPISODE AND VF WITH FAILED ICD SHOCK, AND DURING (B)(6) 2024 EP VISIT FOR CARDIOVERSION, DFT RESULTED IN THREE FAILED SHOCKS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Syncope/Fainting; Ventricular Fibrillation
MAUDE report 19577102 ↗MalfunctionMay 20, 2024Fracture; Ambient Noise Problem; Fracture; Ambient Noise Problem
LEAD WAS EXPLANTED DUE TO NOISE POSSIBLY FROM FRACTURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19354772 ↗
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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