BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKFLEX XL LV LEAD

    MDR report key: 3923883 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14812
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 29, 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

    NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION:FAILURE EVENT OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND INSULATION ABRASION BREACHING THE RING ELECTRODE CABLE LUMEN AT 71.1CM TO 71.3CM FROM THE CONNECTOR PIN. RELIABILITY LABORATORY TECHNICIAN (B)(6).

    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
    401151 QUICKFLEX XL LV LEAD PERMANENT PACEMAKER ELECTRODE NIK ST. JUDE MEDICAL, INC., CRMD 1158T/75 NA

    Patients

    Seq Age Sex Outcome Treatment
    1