BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2920629 · Received January 17, 2013

    Report

    Report Number
    1723170-2012-00705
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE STEALTHARCHIVE FOR THE PATIENT INVOLVED IN THE REPORTED EVENT WAS SENT TO THE MANUFACTURER FOR EVALUATION. IT WAS FOUND THAT THE 3D MODEL LOOKED LIKE A SKULL INSTEAD OF A SKIN MODEL AS IT SHOULD. IT IS LIKELY THAT THE USER DID NOT PROPERLY ADJUST THE THRESHOLD SETTINGS TO BUILD A CORRECT SKIN MODEL AND THIS CAN AFFECT ACCURACY. NO SOFTWARE FAULTS OR ANOMALIES WERE FOUND TO BE THE CAUSE OF THE ALLEGED INACCURACY.

    Additional Manufacturer Narrative · 1

    PT WEIGHT IS NOT AVAILABLE FROM THE SITE. FILES HAVE NOT YET BEEN RECEIVED BY MANUFACTURER FOR INVESTIGATION. SOFTWARE HAS NOT BEEN EVALUATED AS OF THE DATE OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    REVIEWED A SECOND REGISTRATION FROM ANOTHER EXAM ARCHIVE PROVIDED AND DETERMINED THE TRACING PATTERN TO BE THE SAME WITH THE SOFT TISSUE BEING TRACED ON. TRACER PATTERN TRACED OVER SOFT ISSUE. THE TRACING PATTERN ON THE BRIDGE ON THE NOSE IS POOR INDICATING THAT TRACER IS LIKELY SHIFTED FROM THE CORRECT LOCATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED AN INACCURACY WITH THE FUSION NAVIGATION SYSTEM, WHILE IN AN ENT PROCEDURE. THE SURGEON PERFORMED TWO SEPARATE REGISTRATIONS, USING THE TRACER METHOD, AND ALLEGED AN INACCURACY OF 2-4 MM AT THE POSTERIOR SEPTUM. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF NAVIGATION. THERE WAS NO NEGATIVE IMPACT TO THE PT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25651 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR