BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2973139 · Received February 21, 2013

    Report

    Report Number
    1723170-2013-00108
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    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

    FILES HAVE NOT BEEN RETURNED TO MANUFACTURER FOR EVALUATION, SOFTWARE INVESTIGATION NOT COMPLETED AT TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    THE SITE DOES NOT USE THE PATIENT HEAD STRAP TO HOLD THE PATIENT TRACKER ON THE PATIENT'S FOREHEAD. THIS IS UNAPPROVED USE OF THE FUSION NAVIGATION SYSTEM. THE ENTIRE FUSION NAVIGATION SYSTEM WAS REPLACED AT THE SITE. SUSPECT FUSION NAVIGATION SYSTEM HAS BEEN EVALUATED IN HOUSE ALONG WITH SOFTWARE EXAM ARCHIVES. THE SUSPECT SYSTEM PASSED ALL ACCURACY AND PERFORMANCE TESTS WITHOUT ISSUE. UPON COMPLETION OF THE SOFTWARE INVESTIGATION, NO SOFTWARE FAULTS OR ANOMALIES WERE FOUND TO BE THE CAUSE OF THE ALLEGED INACCURACY. THE SITE HAS NOT REPORTED ANY FURTHER ACCURACY ISSUES WITH THEIR NEW SYSTEM.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A LATERAL INACCURACY THAT OCCURRED DURING AN ENT PROCEDURE. SURGERY BEGAN WITH A GOOD TRACER REGISTRATION. SURGEON CHECKED ACCURACY WITH SUPERFICIAL LANDMARKS: MIDLINE BRIDGE OF NOSE AND MEDIAL CANTHUS. ACCURACY CHECKPOINT WAS ESTABLISHED ON MIDLINE BRIDGE OF NOSE USING A REGISTRATION PROBE. HEAD WAS TILTED RIGHT, TOWARD THE SURGEON, AND ACCURACY WAS RE-CHECKED USING ANATOMICAL LANDMARKS AND PREVIOUSLY ESTABLISHED CHECKPOINT. CHECKPOINT FLUCTUATED BETWEEN 1.0-1.9MM WITH FRAZIER SUCTION. TWENTY MINUTES INTO CASE, MIDLINE SHIFT WAS INITIALLY NOTICED LEFT LATERAL OF THE SEPTUM AND INTO THE LEFT NASOLACRIMAL DUCT MORE THAN 2MM. MIDLINE BRIDGE OF THE NOSE WAS CHECKED AND NOTED OFF LEFT LATERAL. SURGEON UNDERSTOOD FRAZIER SUCTION TRACKS THE CENTER OF THE TUBE'S END. THE SURGEON TOUCHED MIDLINE SEPTUM PERPENDICULAR SO CENTER TIP OF SUCTION ENGAGED SEPTUM AND NAVIGATION INDICATED HE WAS OFF OF THE SEPTUM LATERALLY. FRAZIER SUCTION RE-VERIFIED WITH NO PROBLEMS AND NO CHANGE IN RESULTS. CHECKPOINT CHECK READ 3.5MM WITH SHAVER BLADE. SURGEON CONTINUED, TAKING LATERAL SHIFT INTO ACCOUNT AND RE-ESTABLISHED NEW CHECKPOINT WITH STRAIGHT SHAVER BLADE PERPENDICULAR TO SKIN SURFACE ON MIDLINE BRIDGE OF NOSE. NEW CHECKPOINT FLUCTUATED 2.0-3.5 WITH SAME SHAVER BLADE. SURGEON SWITCHED TO RIGHT SINUSES AND DETERMINED NAVIGATION OF THE RIGHT NASOLACRIMAL DUCT WAS OFF LEFT AND ANTERIOR; MEASUREMENTS SHOWED BY 4.5MM. THE SURGEON SUCCESSFULLY COMPLETED THE CASE WITH THE USE OF THE FUSION NAVIGATION SYSTEM. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77134 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR