BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAMIC

    MDR report key: 4181255 · Received October 17, 2014

    Report

    Report Number
    1028232-2014-003789
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 15, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    KRG
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE PROGRAMMER AND MONITORING DEVICE INCLUDING THE PROGRAMMING HEAD AND PSA MODULE WAS INSPECTED. BASED ON THE PROGRAMMER INTERNAL LOG-FILE THE CLINICAL OBSERVATION WAS TRACKED. A REBOOT OF THE DEVICE AND A SUBSEQUENTLY RESTORE OF THE PSA MODULE SETUP WAS DOCUMENTED. THE PROGRAMMER WAS INVESTIGATED IN AN EXTENSIVE STRESS TEST OF ALL COMPONENTS, NO DEVIATION WAS FOUND. IN A NEXT STEP THE ANALYSIS WAS FOCUSED ON THE PSA MODULE. DURING MECHANICAL STRESS TESTS PACING INTERRUPTIONS COULD BE MEASURED. AFTER REPAIR THE PSA MODULE PASSES THE FINAL ACCEPTANCE TEST SUCCESSFULLY.

    Description of Event or Problem · 1

    DURING AN IMPLANTATION PROCEDURE, THE PROGRAMMER SCREEN FROZE. PACING SUPPORT WAS INTERRUPTED FOR A FEW SECONDS WHILE THE PROGRAMMER WAS REBOOTED. THE PATIENT IS REPORTED AS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660646 RENAMIC PROGRAMMER KRG BIOTRONIK SE & CO. KG 365533L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization