BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2884260 · Received December 21, 2012

    Report

    Report Number
    1723170-2012-00784
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE TRACER PATTERN FOR THE EXAM SHOWS A LIMITED AMOUNT OF SURFACE AREA COVERAGE BY THE PROBE. ADDITIONAL POINTS WOULD NEED TO BE TAKEN OVER THE FOREHEAD AND TOWARDS THE TEMPLES TO IMPROVE THE TRACING ACCURACY. THERE IS ALSO SCATTER IN THE FRONT OF THE 3D MODEL WHICH IS NOT IDEAL FOR THE TRACER REGISTRATION TECHNIQUE. THRESHOLDING AND REMOVING THE SCATTER FROM THE IMAGE WOULD IMPROVE THE REGISTRATION. SOFTWARE IS FUNCTIONING AS DESIGNED.

    Additional Manufacturer Narrative · 1

    THE PATIENT WEIGHT HAS BEEN REQUESTED, BUT IS UNKNOWN AT THIS TIME. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE AND WAS UNABLE TO REPRODUCE THE ERROR WHEN NAVIGATING WITH THE SYSTEM ON A HEAD MODEL. SYSTEM NAVIGATED ACCURATELY DURING TESTING.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THE SITE ALLEGED NAVIGATIONL ACCURACY DEGRADED OVER THE COURSE OF A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) UTILIZING THE FUSION ELECTROMAGNETIC NAVIGATION SYSTEM. THEY RE-REGISTERED THE PATIENT WHICH INCREASED ACCURACY FOR A WHILE, BUT AGAIN ACCURACY STARTED TO DEGRADE. THE SURGEON WAS ABLE TO COMPLETE THE CASE WITH THE USE OF NAVIGATION. NO NEGATIVE IMPACT TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR