BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK FLEX LV LEAD

    MDR report key: 4231360 · Received November 6, 2014

    Report

    Report Number
    2017865-2014-18140
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 19, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z1482
    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. FAILURE EVENT OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND THAT A COMPLETE LEAD WAS RECEIVED. AN INSULATION ABRASION BREACHING ONE RING ELECTRODE CABLE AT 81.9 CM TO 82.2 CM FROM THE CONNECTOR PIN WAS NOTED.

    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
    715181 QUICK FLEX LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1156T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1