BEUDAMED
    FDA Adverse Event Death Summary report: N

    GUIDANT

    MDR report key: 1015725 · Received March 17, 2008

    Report

    Report Number
    MW5005900
    Event Type
    Death
    Date Received
    March 17, 2008
    Date of Event
    December 10, 2005
    Report Date
    March 17, 2008
    Manufacturer
    GUIDANT CORP
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE LEAD WIRE FAILED IN THE GUIDANT BIPOLAR ENDOCARDIAL PACING LEAD, MODEL 4456 52 CM, INSIGNIA ULTRA SR MODEL 1190, GUIDANT MFR IN LATE 2005. THE NEXT DAY, ANOTHER GUIDANT BIPOLAR ENDOCARDIAL PACING LEAD, MODEL 4470 52 CM, EXPIRATION DATE 09/21/2005 WAS INSERTED. THE FIRST DEFIBRILLATOR HAD BEEN RECALLED BUT WE, THE FAMILY, DID NOT KNOW THIS. THE SECOND DEFIBRILLATOR, IN ADDITION TO BEING A RECALLED BRAND HAD AN EXPIRATION DATE THREE MONTHS PRIOR TO INSTALLATION. I DO NOT KNOW IF THIS WAS A SINGLE-USE DEVICE THAT WAS REPROCESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT BIPOLAR ENDOCARDIAL PACING LEAD DTB GUIDANT CORP 4456 INSIGNIA ULTRA SR
    2 GUIDANT BIPOLAR ENDOCARDIAL PACING LEAD DTB GUIDANT CORP 4470 INSIGNIA ULTRA SR

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death| H| L| R| S