BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2 DR IS-1/DF-1

    MDR report key: 1681812 · Received May 7, 2010

    Report

    Report Number
    2124215-2010-05252
    Event Type
    Malfunction
    Date Received
    May 7, 2010
    Date of Event
    February 16, 2010
    Report Date
    May 7, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    INVALID DATA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 DR IS-1/DF-1 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR