Skip to content

Plexa ProMRI DF-1 S 75Recalls & reported problems

BIOTRONIK SE & Co. KG · Class 3 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04035479150976), received between Sep 10, 2019 and Jan 28, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Over-Sensing” (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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Over-Sensing1

Patient problems

  • No Known Impact Or Consequence To Patient1
  • Unspecified Infection1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT HAD WOUND INFECTION OF ICD POCKET. THE PATIENT WAS HOSPITALIZED. THE DEVICE WAS EXPLANTED.

    Patient problems: Unspecified Infection

    MAUDE report 11247732 ↗
  • MalfunctionSep 10, 2019Over-Sensing; Over-Sensing

    IT WAS REPORTED THAT 8 MONTHS AFTER THE IMPLANTATION OVERSENSING OCCURRED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8983635 ↗

Other Permanent defibrillator electrodes devices

All Permanent defibrillator electrodes devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.