BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY DS

    MDR report key: 1254060 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40702
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    September 7, 2008
    Report Date
    September 16, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY DS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T125 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention THE DEVICE 4018/BIR186 WAS IMPLANTED 11-SEP-2001| THE DEVICE 0157/104817 WAS IMPLANTED 19-NOV-2002| THE DEVICE 4473/300607 WAS IMPLANTED 11-SEP-2001| THE DEVICE T165/144542 WAS IMPLANTED 16-SEP-2008