BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1974776 · Received December 21, 2010

    Report

    Report Number
    1974776
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 16, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    UNABLE TO UNSCREW ATRIAL ELECTRODE FROM OLD ICD WHILE PERFORMING UPGRADE TO BIVENTRICULAR ICD. FINALLY LOOSENED WITH MOSQUITO CLAMP. THE PATIENT SUFFERED NO UNTOWARD EVENTS FROM THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * DEFIBRILLATOR, IMPLANTABLE LWS ST. JUDE MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *