BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2033630 · Received February 11, 2011

    Report

    Report Number
    1723170-2011-00110
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 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

    MEDTRONIC REP DID TROUBLESHOOTING THAT FOUND THERE HAD NEVER BEEN EXAMS DELETED FROM THE SYSTEM. WALKED THE SITE THROUGH DELETING EXAMS IN THE UNIX SHELL AND THIS WAS SUCCESSFUL.

    Description of Event or Problem · 1

    SURGEON CALLED IN WHILE PREPARING FOR A CASE REPORTING THAT THE SOFTWARE WAS FREEZING UP AT DIFFERENT POINTS AND THEY WERE UNABLE TO LOAD EXAMS. AFTER TROUBLESHOOTING WITH A MEDTRONIC REP THE SYSTEM WORKED PROPERLY AND THE DOCTOR PROCEEDED WITH THE CASE USING THE FUSION NAVIGATION SYSTEM. THERE WAS NO IMPACT ON 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 60 YR