BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY DR

    MDR report key: 1041512 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-32013
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    November 15, 2007
    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
    CA
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC 1871 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other THE DEVICE 4064/303826 WAS IMPLANTED 12-FEB-2001| THE DEVICE 4087/172496 WAS IMPLANTED 06-JAN-2005| THE DEVICE 0148/106063 WAS IMPLANTED 12-FEB-2001