BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC

    MDR report key: 513997 · Received February 13, 2004

    Report

    Report Number
    513997
    Event Type
    Death
    Date Received
    February 13, 2004
    Date of Event
    January 21, 2004
    Report Date
    February 13, 2004
    Manufacturer
    MEDTRONIC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2004 PT UNDERWENT ENDOGRAFT FOR AAA. POST PROCEDURE, PT'S GROIN OOZING WITH A HEMATOMA. PT'S H&H DECREASED AND PT WAS THEN TAKEN TO THE O.R. FOR REPAIR OF A PSEUDOANEURYSM OF THE FEMORAL ARTERY. THE NEXT DAY AT 6:50AM THE PT WAS FOUND ON THE FLOOR UNRESPONSIVE. UNABLE TO RESUSCITATE AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC VASCULAR ENDOGRAFT MIH MEDTRONIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| R