BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY AVT

    MDR report key: 1041563 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31980
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    September 5, 2007
    Report Date
    January 31, 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
    US
    Reporter Occupation
    NURSE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY AVT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC A135 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention THE DEVICE 4054/437971 WAS IMPLANTED 09-MAR-2004| THE DEVICE 0158/135798 WAS IMPLANTED 09-MAR-2004