BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND IS-1 BI POSITIVE FIX

    MDR report key: 1041887 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34766
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IS-1 BI POSITIVE FIX IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4087 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention THE DEVICE 1298/209285 WAS IMPLANTED 05-AUG-2005| THE DEVICE 4469/448083 WAS IMPLANTED 05-AUG-2005| THE DEVICE 4470/577132 WAS IMPLANTED 25-MAR-2008