BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2 VR

    MDR report key: 1041461 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-32073
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    January 2, 2008
    Report Date
    January 2, 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
    US
    Reporter Occupation
    OTHER

    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 60 YR Required Intervention THE DEVICE 0125/312637 WAS IMPLANTED 03-SEP-1998| THE DEVICE 1782/502823 WAS IMPLANTED 03-SEP-1998| THE DEVICE 1793/303226 WAS IMPLANTED 27-JAN-2000