BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY DS VR

    MDR report key: 1042685 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33956
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY DS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T135 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other THE DEVICE 6921 TAD001 WAS USED DURING THE EVENT.| THE DEVICE 6917 WC0047 WAS USED DURING THE EVENT.| THE DEVICE 0155/342626 WAS IMPLANTED 13-NOV-2000| THE DEVICE 6921 TAD001 WAS USED DURING THE EVENT.| THE DEVICE 6917 WC0047 WAS USED DURING THE EVENT.