BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND 2

    MDR report key: 1042034 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34605
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 20, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 63 YR Other THE DEVICE F110/000309 WAS IMPLANTED 17-MAR-2008| THE DEVICE 0181/109393 WAS IMPLANTED 17-MAR-2008