BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY DR HE

    MDR report key: 1043612 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33021
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    January 31, 2008
    Report Date
    January 31, 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 61 YR Required Intervention THE DEVICE 4543/124549 WAS IMPLANTED 12-FEB-2007| THE DEVICE 1190/125914 WAS IMPLANTED 01-JUL-2005| THE DEVICE 4087/241240 WAS IMPLANTED 01-JUL-2005| THE DEVICE 6481 032054 WAS USED DURING THE EVENT.