BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REOCOR S

    MDR report key: 19985011 · Received August 14, 2024

    Report

    Report Number
    1028232-2024-04265
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    March 7, 2024
    Report Date
    September 25, 2024
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    OVJ
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT, THE EXTERNAL PACEMAKER INCLUDING THE REDEL ADAPTER WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. WITHIN THIS ANALYSIS THE DEVICE WAS VISUALLY, MECHANICALLY AND FUNCTIONALLY INSPECTED. THE QUALITY DOCUMENTS ASSOCIATED WITH THIS DEVICE WERE RE-INVESTIGATED. THE REVIEW OF THESE QUALITY DOCUMENTS DID NOT SHOW ANY DEVIATION. DURING THE ANALYSIS, THE CLINICAL OBSERVATION COULD BE CONFIRMED. THE EXTERNAL PACEMAKER DID NOT MEET THE SPECIFIED 30-SECOND BACKUP-PACING TIME. A DAMAGED CAPACITOR OF THE BACKUP-PACING FUNCTION WAS IDENTIFIED AS THE CAUSE FOR THIS BEHAVIOR. HOWEVER, APART FROM THE BACKUP-PACING TIME, THE DEVICE WORKED AS EXPECTED. 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. THE EXTERNAL PACEMAKER COULD BE SUCCESSFULLY REPAIRED. AFTERWARDS, THE DEVICE PROVED TO BE FULLY FUNCTIONAL. ALL MEASUREMENT RESULTS WERE WITHIN THE SPECIFICATIONS. THE REDEL ADAPTER RETURNED WITH THE EXTERNAL PACEMAKER WAS INVESTIGATED. THE ANALYSIS OF THE REDEL ADAPTER DID NOT INDICATE ANY MALFUNCTION. THE INFORMATION YOU PROVIDED HAS BEEN ENTERED INTO OUR QUALITY SYSTEM AS A COMPLAINT. THESE TYPES OF COMPLAINTS ARE USED TO EVALUATE SYSTEMS AND DEVICE PERFORMANCE THROUGHOUT OUR ORGANIZATION AND HELP TO MAINTAIN AND IMPROVE THE PERFORMANCE OF OUR DEVICES.

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED THAT THE BATTERY TEST FAILED FOR THIS DEVICE. FURTHER INFORMATION FROM USER REPORT RECEIVED ON (B)(6) 2024 INDICATE THAT THE DEVICE WAS CONNECTED TO AN ICU PATIENT AND STOPPED PACING IMMEDIATELY AFTER REMOVING THE BATTERY INSTEAD OF BACK UP PACING FOR 30 SECONDS WHICH IS WHY THE EVENT BECAME REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2371919 REOCOR S EXTERNAL PACEMAKER OVJ BIOTRONIK SE & CO. KG 365528

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization