BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND 2

    MDR report key: 1041982 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34665
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND 2 IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4096 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention THE DEVICE F110/000220 WAS IMPLANTED 26-FEB-2008| THE DEVICE 4096/138379 WAS IMPLANTED 26-FEB-2008| THE DEVICE 0181/105865 WAS IMPLANTED 26-FEB-2008