BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY DR

    MDR report key: 1041894 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34745
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 21, 2008
    Report Date
    March 21, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/53-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 64 YR Other THE DEVICE 4244/205920 WAS IMPLANTED 09-NOV-1998| THE DEVICE 0125/313757 WAS IMPLANTED 09-NOV-1998| THE DEVICE 1821/224064 WAS IMPLANTED 09-NOV-1998| THE DEVICE T165/141709 WAS IMPLANTED 27-MAR-2008