BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL PACEMAKERS

    MDR report key: 23744506 · Received December 8, 2025

    Report

    Report Number
    MW5180111
    Event Type
    Injury
    Date Received
    December 8, 2025
    Report Date
    December 3, 2025
    Manufacturer
    BIOTRONIK SE & CO. KG.
    Product Code
    OVJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    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. PT CODE: 1762. DEVICE CODE: 4019. PROCODE: OVJ. REF REPORT: MW5180110.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2796530 EXTERNAL PACEMAKERS PULSE GENERATOR, EXTERNAL PACEMAKER, DUAL-CHAMBER OVJ BIOTRONIK SE & CO. KG. REOCOR D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening