BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2 DR

    MDR report key: 1253756 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40603
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 16, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/53-08
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T165 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention THE DEVICE 0185/111039 WAS IMPLANTED 11-JAN-2005| THE DEVICE 4087/227280 WAS IMPLANTED 11-JAN-2005| THE DEVICE 4088/209047 WAS IMPLANTED 11-JAN-2005