BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSITE LV

    MDR report key: 3924206 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-15134
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 17, 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. EVALUATION DESCRIPTION: FAILURE EVENT OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND THAT A PARTIAL LEAD WAS RECEIVED. INSULATION ABRASION BREACHING THE RING ELECTRODE CABLE LUMEN WAS NOTED AT 3.1 CM TO 4.1 CM FROM THE DISTAL TIP. (B)(4).

    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
    399831 QUICKSITE LV PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1056T/75 NA

    Patients

    Seq Age Sex Outcome Treatment
    1