BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2 VR

    MDR report key: 1254040 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40612
    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
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    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 Required Intervention THE DEVICE F102/000775 WAS IMPLANTED 16-SEP-2008| THE DEVICE 0164/101113 WAS IMPLANTED 01-OCT-2004