BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITALITY

    MDR report key: 1719909 · Received June 11, 2010

    Report

    Report Number
    2124215-2010-12409
    Event Type
    Death
    Date Received
    June 11, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 2, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT EXPLANTED AND WAS LIKELY BURIED WITH THE PATIENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS DEVICE EXPIRED. IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING AN UPGRADE PROCEDURE. THE PATIENT DEVELOPED PULSELESS ELECTRICAL ACTIVITY SHORTLY AFTER THE POCKET WAS OPENED. IT WAS SUSPECTED THIS WAS DUE TO THE ANESTHESIA. THERE WERE NO PRODUCT PERFORMANCE ALLEGATIONS AGAINST THE FUNCTIONALITY OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T180

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death 0185| T180