BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 3781704 · Received April 30, 2014

    Report

    Report Number
    1723170-2014-00439
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT PROVIDED DUE TO CANADIAN PATIENT PRIVACY REGULATIONS. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE SYSTEM MONITOR INTERMITTENTLY FLICKERS DURING USE OF NAVIGATED BLADE AND MICRODEBRIDER INSTRUMENTS. THE FLICKERING DID NOT APPEAR ON EXTERNAL SLAVE MONITOR THAT WAS BEING USED. THE FLICKERING DOES NOT OCCUR IMMEDIATELY UPON ACTIVATION OF THE MICRODEBRIDER BUT WAS FOUND TO BE MORE FREQUENT WHEN SURGEON REMOVES THEIR FOOT FROM THE MICRODEBRIDER PEDAL. THE SYSTEM MONITOR WAS ABOUT 8-10 FEET AWAY FROM THE PATIENT. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260377 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1