BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2020580 · Received February 10, 2011

    Report

    Report Number
    1723170-2011-00106
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SOFTWARE EVALUATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE FROM THE OPERATING STAFF REPORTING THAT DURING AN ENT CASE, THE EMITTER WAS NOT BEING RECOGNIZED. THE EMITTER HAD RED STATUS. MEDTRONIC REPRESENTATIVE WALKED THROUGH TROUBLESHOOTING, THE SYSTEM RE-BOOTED AND THE ISSUE WAS RESOLVED. THE SURGEON CONTINUED THE CASE WITH THE USE OF THE FUSION NAVIGATION SYSTEM WITH NO IMPACT ON THE PATIENT 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 62 YR