BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDANT

    MDR report key: 748535 · Received July 21, 2005

    Report

    Report Number
    MW1036132
    Event Type
    Injury
    Date Received
    July 21, 2005
    Date of Event
    August 30, 2004
    Report Date
    July 21, 2005
    Manufacturer
    GUIDANT
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    GUIADANT PRIZM MODE 1861 INSTALLED IN 2002. AFTER MUCH ATRIAL FIBRILLATION ON 30AUGUST 04, TESTING BY GUIDANT FIELD REP SHOWED DEVICE HAD FAILED -INSULATION BREAKDOWN CAUSING ATRIAL LEAD SHORTING-. ATRIAL LEAD REVISION. STAPH INFECTION. DEVICE REMOVED. ALL LEADS REMOVED. VITALITY DS MODEL T125 INSTALLED. I DO NOT KNOW WHAT HAPPENED TO THE DEVICE WHEN IT WAS REMOVED SO I DO NOT KNOW IF IT'S AVAILABLE FOR EVALUATION. I PRESUME THE DR RETURNED IT TO THE MFR BUT I DO NOT KNOW. THEREFORE, I CAN NOT GIVE YOU A DATE OF RETURN. THE REMOVAL WAS ON 15 NOV 04. LEADS REMOVED ON 16 NOV 04.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT AUTOMATIC IMPLANTABLE CARDIAC DEFIBRILLATOR -AICD- LWS GUIDANT 1861 *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R