BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC, INC.

    MDR report key: 411665 · Received August 12, 2002

    Report

    Report Number
    411665
    Event Type
    Death
    Date Received
    August 12, 2002
    Date of Event
    July 11, 2002
    Report Date
    August 9, 2002
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE TO IMPLANT ICD, PT CODED AND DIED. POSSIBLY DUE TO PERFORATION OF RIGHT VENTRICLE BY LEAD INSERTION ACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC, INC. ICD LWS MEDTRONIC, INC. 6947 *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death