BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL PACEMAKERS

    MDR report key: 23742395 · Received December 8, 2025

    Report

    Report Number
    MW5180098
    Event Type
    Injury
    Date Received
    December 8, 2025
    Report Date
    December 3, 2025
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    OVJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE EXTERNAL PACEMAKER DEVICE, SPECIFICALLY THE REOCOR (MANUFACTURER: BIOTRONIK; MODELS: REOCOR S, REOCOR D), UNEXPECTEDLY CEASED OPERATION DURING THE BATTERY REPLACEMENT PROCESS, LEADING TO THE PATIENT EXPERIENCING CARDIAC ARREST. THE ORIGINAL MANUFACTURER'S MANUAL STATED THAT THERE IS A 30-SECOND WINDOW (DURING WHICH THE CIRCUIT BOARD MAINTAINS POWER/IS SUPPORTED BY RESIDUAL POWER) FOR BATTERY REPLACEMENT. HOWEVER, SEVEN UNITS OF THE EQUIPMENT ARE CURRENTLY IN A FAILURE/INOPERATIVE STATE. PT CODE: 1762. DEVICE CODES: 1435, 3023. REF REPORTS: MW5180093, MW5180094, MW5180095, MW5180096, MW5180097, MW5180099, MW5180100.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2772652 EXTERNAL PACEMAKERS PULSE GENERATOR, EXTERNAL PACEMAKER, DUAL CHAMBER OVJ BIOTRONIK, INC. REOCOR S, REOCOR D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening