BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY DR HE

    MDR report key: 1042256 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34379
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 13, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY DR HE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention THE DEVICE 4312/047399 WAS IMPLANTED 06-DEC-1991| THE DEVICE 4312/024032 WAS IMPLANTED 06-DEC-1991| THE DEVICE T180/ WAS IMPLANTED