BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2181268 · Received July 8, 2011

    Report

    Report Number
    1723170-2011-01201
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLETED INVESTIGATION FINDS THAT THIS IS AN ISSUE WITH 'RECOGNITION,' NOT WITH 'VERIFICATION.' VERIFICATION DOES INDEED SWITCH THE TOOL THAT IS BEING NAVIGATED, AND VERIFICATION IS NOT AFFECTED BY THIS 'RECOGNITION' ISSUE. THIS ISSUE WAS ADDRESSED IN ENT 2.2.1. NO FURTHER ISSUES REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REP REPORTED THE USER VERIFIED THE STRAIGHT SUCTION PROBE IN THE HEAD FRAME DIVOT AND 5 MINUTES INTO THE ENT CASE, THE SYS SHOWED IT AS AN ELEVATOR PROBE INSTEAD. HE ALSO REPORTED THE SOFTWARE KEPT REVERTING BACK TO THE REGISTRATION SCREEN. THEY RE-VERIFIED THE STRAIGHT SUCTION PROBE AND THIS RESOLVED THE ISSUE. THE SURGERY WAS COMPLETED WITH THE USE OF THE FUSION NAVIGATION SYS. NO IMPACT ON PT OUTCOME REPORTED.

    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 50 YR