BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK FLEX LV LEAD

    MDR report key: 3923193 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14510
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 10, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    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 OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND THAT THE INSULATION WAS ABRADED AT 65.7 CM TO 67.0 CM AND AT 69.6 CM TO 69.8 CM FROM THE CONNECTOR PIN.

    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
    401938 QUICK FLEX LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1156T/75 NA

    Patients

    Seq Age Sex Outcome Treatment
    1