BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2152996 · Received June 17, 2011

    Report

    Report Number
    1723170-2011-01109
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC REP REPLACED THE COMPUTER WHICH CORRECTED THE PROBLEM. SYSTEM IS FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    A SITE REP REPORTED THAT THEY HAD ISSUES DURING AN ENT SURGERY AS THE SCREEN FROZE DURING REGISTRATION. THE NURSE WAS UNABLE TO MOVE THE MOUSE OR DO ANYTHING ON THE SCREEN. SHE SAID THE SCREEN WAS FROZEN FOR ABOUT 2 MINS BEFORE SHE CALLED IN. MEDTRONIC TECHNICAL SERVICES WALKED HER THROUGH TROUBLESHOOTING TO ATTEMPT TO EXIT THE SOFTWARE. THIS WAS UNSUCCESSFUL. AFTER RE-BOOTING THE SYSTEM, THEY WERE ABLE TO PROCEED IN THE SOFTWARE NORMALLY AND THE SYSTEM DID NOT FREEZE. THE SURGEON COMPLETED THE SURGERY WITH THE USE OF THE FUSION NAVIGATION SYSTEM. THERE WAS NO IMPACT ON THE PT OUTCOME.

    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 49 YR