BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2043193 · Received February 24, 2011

    Report

    Report Number
    1723170-2011-00157
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. SYSTEM EVALUATION HAS NOT BEEN COMPLETED AT THIS TIME.

    Description of Event or Problem · 1

    THE SURGEON REPORTED SYSTEM FREEZE WHEN LOADING AN EXAM FOR AN ENT PROCEDURE. THE EXAM HAS 148 SLICES AND SAYS TRANSFER COMPLETE BUT THEN THE SYSTEM FREEZES. THEY HAD TO DO A HARD SHUT DOWN. THE SURGEON WAS ABLE TO MOVE FORWARD IN THE SOFTWARE TO SELECT A SURGEON PROFILE BUT THE SYSTEM FROZE AGAIN. THE SURGEON OPTED TO DISCONTINUE THE USE OF THE FUSION NAVIGATION SYSTEM AND RE-SCHEDULE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION NAVIGATION SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. FUSION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK