BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC

    MDR report key: 41015 · Received September 27, 1996

    Report

    Report Number
    41015
    Event Type
    Death
    Date Received
    September 27, 1996
    Date of Event
    August 7, 1996
    Report Date
    September 26, 1996
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PACEMAKER LEAD PERFORATED THE PT'S HEART AND PRODUCED HEMOPERICARDIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC Implant LEAD - 45CM (BIPOLAR CONNECTOR) DTB MEDTRONIC, INC. 4068 *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death THERA DR 7961 IU DUAL CHAMBER RATE RESPONSIVE PACE