BEUDAMED
    FDA Adverse Event Death Summary report: N

    5 FR NBIH BIPOLAR ELECTRODE

    MDR report key: 33460 · Received June 12, 1996

    Report

    Report Number
    33460
    Event Type
    Death
    Date Received
    June 12, 1996
    Date of Event
    May 28, 1996
    Report Date
    June 4, 1996
    Manufacturer
    U.S.C.I. DIV. C.R. BARD, INC.
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT CARDIAC CATH. ATTEMPTING ANGIO-PLASTY AT END OF PROCEDURE DEVELOPED HEART BLOCK AND A TEMPORARY PACER WAS INSERTED. SHORTLY THEREAFTER PT FOUND IN EMD. PT EXPIRED. CAUSE OF DEATH WAS HEMOPERICARDIUM CAUSED BY TEMPORARY TRANSVENOUS PACEMAKER WIRE PERFORATION. HEART MUSCLE VERY FRIABLE DUE TO DAMAGE FROM MI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 FR NBIH BIPOLAR ELECTRODE BIPOLAR ELECTRODE DYG U.S.C.I. DIV. C.R. BARD, INC. 07FF1565

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death