BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2081232 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00859
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER SOFTWARE INVESTIGATION, THE SYSTEM IS FUNCTIONING AS DESIGNED AND THIS IS A SETUP AND TRAINING RELATED RECORD. MOVING THE INSTRUMENT THROUGH THE FIELD QUICKLY, CAN INCREASE THE GEOMETRY ERROR OF THE INSTRUMENT WHICH, THEREFORE, DESIGNED TO CHANGE TO RED STATUS. ADDITIONALLY, METAL INTERFERENCE CAN CAUSE A REDUCED FIELD. A COMPUTER HARDWARE UPGRADE PATH IS AVAILABLE THAT WILL PROVIDE AN INCREASED UPDATE RATE IF THE USER DESIRES THE FASTER UPDATES WHEN MOVING THE INSTRUMENT THROUGH THE FIELD. NOT A SOFTWARE DEFECT.

    Description of Event or Problem · 1

    MENT REP REPORTED THE SURGEON HAD DIFFICULTY TRACKING WITH THE FUSION SYSTEM. THEY HAVE EXPERIENCED FLICKERING RED/GREEN STATUS WITH EVERY INSTRUMENT. THE FUSION EMITTER WAS POSITIONED 12 INCHES ABOVE THE OPERATING ROOM BED AND THE PT WAS ELEVATED FROM THE BED WITH A DONUT. THE SURGEON ALLEGED HE WAS INACCURATE TO THE RIGHT BY 3 CM. SURGEON COMPLETED SURGERY WITH NAVIGATION. 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