BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REOCOR D

    MDR report key: 22570028 · Received July 22, 2025

    Report

    Report Number
    1028232-2025-03444
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    July 7, 2025
    Report Date
    September 4, 2025
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    OVJ
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT, THE EXTERNAL PACEMAKER WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. WITHIN THIS ANALYSIS THE DEVICE WAS VISUALLY, MECHANICALLY AND FUNCTIONALLY INSPECTED. DURING THE ANALYSIS, THE CLINICAL OBSERVATION COULD BE CONFIRMED. THE EXTERNAL PACEMAKER DID NOT MEET THE SPECIFIED 30-SECOND BACKUP-PACING TIME. THE BACKUP PACING TIME DURING THE BATTERY REPLACEMENT WAS 0 SECONDS. A DAMAGED CAPACITOR OF THE BACKUP-PACING FUNCTION WAS IDENTIFIED AS THE CAUSE FOR THIS BEHAVIOR. DURING THE VISUAL AND MECHANICAL EXAMINATION, IT WAS ALSO FOUND THAT THE DEVICE HAD VARIOUS EXTERNAL DAMAGES, WHICH SUGGEST THAT IT HAD BEEN DROPPED OR SIMILAR. IN ADDITION, THE DEVICE SHOWED INTERNAL LIQUID DAMAGE. NEVERTHELESS, THE EXTERNAL PACEMAKER WAS ABLE TO PROVIDE THERAPY AT THE TIME OF THE EXAMINATION. THE ABILITY OF THE DEVICE TO SENSE CARDIAC SIGNALS AS WELL AS TO DELIVER ANTI-BRADYCARDIA THERAPY WAS TESTED AND PROVED TO BE FULLY FUNCTIONAL. DUE TO THE SEVERE DAMAGE, SAFE CONTINUED OPERATION OF THE DEVICE CANNOT BE GUARANTEED. REPAIR IS THEREFORE NOT POSSIBLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NO BACKUP PACING FUNCTION WAS ACTIVATED WHEN THE BATTERY WAS REPLACED. AFTER REPLACING THE BATTERY, THE PACER IMMEDIATELY RESUMED FUNCTIONING. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943924 REOCOR D EXTERNAL PACEMAKER OVJ BIOTRONIK SE & CO. KG 365529

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization