BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKFLEX XL LV LEAD

    MDR report key: 3923212 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14524
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 13, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z1483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. NO COMPLAINT WAS RECEIVED WITH RETURN OF DEVICE. FAILURE EVENT WAS OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND THAT THE INSULATION AND CABLE COATING WERE ABRADED AT 69.0 CM TO 69.3 CM FROM THE CONNECTOR PIN. ONE RING ELECTRODE CABLE WAS FRACTURED AT THE SAME LOCATION. ELECTRICAL TESTING FOUND A SHORT CIRCUIT BETWEEN THE COILS.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401970 QUICKFLEX XL LV LEAD PERMANENT PACEMAKER ELECTRODE NIK ST. JUDE MEDICAL, INC., CRMD 1158T/75 NA

    Patients

    Seq Age Sex Outcome Treatment
    1