BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND 2

    MDR report key: 1042696 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33951
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 22, 2008
    Report Date
    February 27, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 Other THE DEVICE 0185/183746 WAS IMPLANTED 04-DEC-2007| THE DEVICE M177/200473 WAS IMPLANTED 04-DEC-2007| THE DEVICE 4543/128807 WAS IMPLANTED 04-DEC-2007