BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONICS, INC.

    MDR report key: 228844 · Received June 25, 1999

    Report

    Report Number
    228844
    Event Type
    Death
    Date Received
    June 25, 1999
    Date of Event
    May 25, 1999
    Report Date
    June 24, 1999
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT EXPIRED DURING PACEMAKER PLACEMENT. THE VENTRICULAR LEADS PERFORATED THE SUPERIOR VENA CAVA INTO THE RIGHT CHEST; PATIENT SUFFERED HEMOTHORAX AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONICS, INC. DUAL CHAMBER PACEMAKER LWP MEDTRONIC, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death