BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REOCOR D

    MDR report key: 22994169 · Received September 8, 2025

    Report

    Report Number
    1028232-2025-04407
    Event Type
    Malfunction
    Date Received
    September 8, 2025
    Date of Event
    July 29, 2025
    Report Date
    September 8, 2025
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    OVJ
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE FAILURE HAS BEEN CONFIRMED. IN ADDITION, THE PROTECTIVE COVER WAS MISSING, AND THE UPPER PART OF THE REDEL ADAPTER HOUSING WAS FOUND TO BE DAMAGED. THE FOLLOWING REPAIR AND MAINTENANCE STEPS WERE CARRIED OUT: REPLACEMENT OF A COMPONENT ON THE PACEMAKER BOARD. INSTALLATION OF A NEW PROTECTIVE COVER. REPLACEMENT OF THE UPPER PART OF THE REDEL ADAPTER HOUSING. A FULL FACTORY RELEASE INSPECTION WAS COMPLETED IN ACCORDANCE WITH OUR CURRENT SPECIFICATIONS. THIS INCLUDED FUNCTIONAL TESTING AS WELL AS STANDARD ELECTRICAL SAFETY CHECKS. THE DEVICE EXHIBITS NORMAL SIGNS OF USE, WHICH WERE NOT ADDRESSED DURING THE REPAIR PROCESS. THE DEVICE IS READY TO LEAVE OUR FACILITY WITH THE CURRENT HARDWARE AND FIRMWARE VERSIONS INSTALLED.

    Description of Event or Problem · 0

    THE DEVICE WAS RETURNED FOR REPAIR DUE TO DEFECTIVE CAPACITOR RESULTING IN NO BACKUP PACING DURING BATTERY REPLACEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2055636 REOCOR D EXTERNAL PACEMAKER OVJ BIOTRONIK SE & CO. KG 365529

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown