BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 3875215 · Received June 12, 2014

    Report

    Report Number
    3875215
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    April 3, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A ABDOMINAL AORTA REPAIR, THE MEDTRONIC AORTIC GRAFT FAILED TO OPEN PROXIMALLY. AN AORTIC BALLOON USED TO OPEN SUPRA RENAL FIXATION AT THE PROXIMAL END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346592 MEDTRONIC EDURANT II MIH MEDTRONIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR