BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSITE XL LV

    MDR report key: 3923183 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14494
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 6, 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 Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR ROUTINE FOLLOW-UP. FLUOROSCOPY SHOWED AN INSULATION ABRASION ON THE LEFT VENTRICULAR LEAD. THE DEVICE WAS PROGRAMMED TO RIGHT VENTRICLE AND ATRIAL PACING ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401562 QUICKSITE XL LV PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1058T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR