BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSITE XL LV

    MDR report key: 1223819 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03463
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    September 17, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMAP030054
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD CAUSED DIAPHRAGMATIC STIMULATION. A NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WOULD BE IMPLANTED TO ALLOW POSSIBLE RESOLUTION OF THE STIMULATION THROUGH PROGRAMMING. IT WAS NOTED THAT IF THAT WAS NOT SUCCESSFUL, THE LEAD WOULD BE REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKSITE XL LV PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1058T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1