BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSITE XL LV

    MDR report key: 1896338 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04816
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    August 11, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPOTED THAT THE LEAD EXHBITED HIGH CAPTURE THRESHOLD OF 3.5 V AT 1.5 MS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKSITE XL LV PERMANENT PACEMAKER ELECTRODE NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1058T/75 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR