BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 3910052 · Received July 2, 2014

    Report

    Report Number
    1723170-2014-00711
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    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

    PATIENT INFORMATION HAS NOT BEEN PROVIDED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE EMITTER IMMEDIATELY DISPLAYED RED STATUS AND DISPLAYED AN ERROR MESSAGE OF "AXIEM EMITTER LOW DRIVE ERROR." DIAGNOSTIC EVALUATION SHOWED A FAULT ON COIL #3. THE REPORTED EVENT WAS CONFIRMED. THE CAUSE WAS AN ELECTRICAL OPEN ON COIL #3. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE AND REPLACED THE EMITTER. THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOW PROVIDED.PATIENT WEIGHT NOT AVAILABLE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE THE SYSTEM STOPPED TRACKING. THE SURGEON CHOSE TO COMPLETE THE SURGERY WITHOUT NAVIGATION. THERE WAS NO REPORTED IMPACT TO THE OUTCOME OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386309 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR