BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND IS-1 BI POSITIVE FIX

    MDR report key: 1041565 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31982
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    September 7, 2007
    Report Date
    January 22, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    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 79 YR Other THE DEVICE 0158/119486 WAS IMPLANTED 15-JUL-2003| THE DEVICE 4538/155034 WAS IMPLANTED 11-AUG-2004| THE DEVICE A135/103849 WAS IMPLANTED 15-JUL-2003| THE DEVICE H170/502253 WAS IMPLANTED 11-AUG-2004