BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 3062048 · Received April 16, 2013

    Report

    Report Number
    1723170-2013-00280
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SOFTWARE INVESTIGATION OF THE SYSTEM ARCHIVE FOUND THAT THE RETURNED LOGS WERE WERE UNUSABLE BECAUSE THEY WERE NOT ACTUALLY LOG FILES. HOWEVER, PER TROUBLESHOOTING AT THE SITE, WHEN THE EMITTER WAS POSITIONED CLOSER TO THE REFERENCE HEAD THE INSTRUMENT TRACKED AS EXPECTED. THE MOST LIKELY CAUSE OF THE REPORTED EVENT WAS INCORRECT SETUP. THE SOFTWARE WAS FUNCTIONING AS DESIGNED.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS NOT AVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE TESTED THE SYSTEM AT THE FACILITY. HE MOVED THE SYSTEM INTO ANOTHER LOCATION AND CHANGED THE OR BED SETUP. TESTED ORIGINAL EMITTER AND ACCURACY. ALL TESTS CONFIRMED THE SYSTEM WAS WITHIN SPECIFICATIONS. TESTED SYSTEM WITH REPLACEMENT EMITTER AND OBTAINED THE SAME RESULTS. THE ORIGINAL EMITTER WAS PUT BACK ON THE SYSTEM AND A DEMO SYSTEM WAS INSTALLED AT THE SITE FOR ISSUE RESOLUTION. NO FURTHER ISSUES REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT AFTER PERFORMING A TRACER REGISTRATION FOR A FESS (FUNCTIONAL ENDOSCOPIC SINUS SURGERY) THE DOCTOR FELT ACCURATE ON THE ANTERIOR ANATOMY, BUT ALLEGED NAVIGATION WAS A FEW MILLIMETERS OFF ON THE POSTERIOR/ SKULL BASE ANATOMY. HE REPORTED WHEN HE WAS TOUCHING THE SKULL BASE SUPERFICIALLY IT SHOWED THE PROBE ON THE BRAIN. BEFORE THE PERFORMING THE TRACER REGISTRATION, THE 3D MODEL AND 2D IMAGES HAD BEEN ADJUSTED AND THE REP VERIFIED THAT THE SURGEON TRACED BACK TO THE EARS. THERE WAS ONE METAL CLAMP HOLDING WIRES THAT WAS IN PLACE DURING THE TRACE. SURGEON WAS USING THE CURVED SUCTION AND THE FRAZIER SUCTION. THE SURGEON CONTINUED USING NAVIGATION FOR THE REST OF THE CASE. THERE WAS NO REPORTED NEGATIVE IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161994 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR