BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTERMEDICS PACEMAKER LEAD

    MDR report key: 35375 · Received July 9, 1996

    Report

    Report Number
    35375
    Event Type
    Death
    Date Received
    July 9, 1996
    Date of Event
    February 21, 1996
    Report Date
    March 27, 1996
    Manufacturer
    CARDIAC CONTROL SYSTEMS, INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 70-YR-OLD FEMALE ADMITTED FOR INSERTION OF PACEMAKER DUE TO COMPLAINTS OF DIZZINESS AND FAINTING SPELLS. PROCEDURE PERFORMED, AT CLOSE OF PROCEDURE (WHILE STILL IN OR) PT COMPLAINED OF CHEST DISCOMFORT. PT LOST CONSCIOUSNESS, UNABLE TO OBTAIN PULSE. CODE CALLED, UNABLE TO RESUSCITATE. PT EXPIRED. AUTOPSY PERFORMED, RESULTS NOT AVAILABLE AS OF 3/27/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMEDICS PACEMAKER LEAD Implant PACEMAKER LEAD DTB CARDIAC CONTROL SYSTEMS, INC. 425-04 950509

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death