BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2 VR

    MDR report key: 1115649 · Received August 14, 2008

    Report

    Report Number
    2124215-2008-35452
    Event Type
    Injury
    Date Received
    August 14, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 8, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/55-07
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T175 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention THE DEVICE 1600/757919 WAS IMPLANTED 31-AUG-1994| THE DEVICE 1857/700106 WAS IMPLANTED 19-APR-2002| THE DEVICE 0040/101674 WAS IMPLANTED 09-MAY-1988| THE DEVICE 0040/101940 WAS IMPLANTED 09-MAY-1988| THE DEVICE 6917 WCO396 WAS USED DURING THE EVENT.| THE DEVICE 1745/500947 WAS IMPLANTED 30-DEC-1997| THE DEVICE 0181/100884 WAS IMPLANTED 02-MAR-2006| THE DEVICE 1550/690880 WAS IMPLANTED 14-FEB-1991| THE DEVICE 1500/613614 WAS IMPLANTED 20-MAY-1988