BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC INC

    MDR report key: 97494 · Received June 9, 1997

    Report

    Report Number
    97494
    Event Type
    Death
    Date Received
    June 9, 1997
    Date of Event
    April 25, 1997
    Report Date
    June 5, 1997
    Manufacturer
    MEDTRONIC INC
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PERFORATED RIGHT ATRIAL WALL DURING INSERTION OF PACER LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INC Implant IMPLANTABLE PACING LEAD DTB MEDTRONIC INC LAQ 009483V *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Death