BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY VR

    MDR report key: 1041412 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-32136
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    January 3, 2008
    Report Date
    January 3, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/53-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC 1870 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other THE DEVICE T175/127531 WAS IMPLANTED| THE DEVICE 1793/300679 WAS IMPLANTED 05-FEB-1999| THE DEVICE 0125/000813 WAS IMPLANTED 18-JUL-1995