BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY DR HE

    MDR report key: 1042272 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34367
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 12, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    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 DR HE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention THE DEVICE 6483 507040 WAS USED DURING THE EVENT.| THE DEVICE 1852/204297 WAS IMPLANTED 13-FEB-2004| THE DEVICE 6487 507020 WAS USED DURING THE EVENT.| THE DEVICE 0158/135884 WAS IMPLANTED 13-FEB-2004| THE DEVICE 6481 301324 WAS USED DURING THE EVENT.