BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXTEND IS-1 BI POSITIVE FIX

    MDR report key: 637616 · Received February 9, 2004

    Report

    Report Number
    2124215-2004-06507
    Event Type
    Death
    Date Received
    February 9, 2004
    Date of Event
    October 30, 2003
    Report Date
    October 30, 2003
    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

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE TRANSVENOUS ATRIAL LEAD PASSED AWAY TWO DAYS AFTER THE IMPLANT PROCEDURE. THERE WAS A POSSIBLE CARDIAC PERFORATION FROM THE ATRIAL LEAD AS EVIDENCED BY A PNEUMOTHORAX SEEN ON A CHEST X-RAY.

    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 UNKNOWN Death