BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2931759 · Received January 28, 2013

    Report

    Report Number
    1723170-2013-00059
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 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

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE AT TIME OF THIS REPORT. NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REPRESENTATIVE REPORTED THAT WHILE IN AN ENT PROCEDURE, THE SOFTWARE BECAME UNRESPONSIVE FOLLOWING REGISTRATION. REGISTRATION WAS SUCCESSFUL; HOWEVER, THEY EXITED THE SOFTWARE AND RE-ENTERED TO GAIN RESPONSE. IN THE NAVIGATION ACTIVITY, TRACKING WAS INTERMITTENT; CROSS HAIRS WERE GREEN IN THE SAGITTAL AND CORONAL VIEW BUT RED IN THE AXIAL VIEW. EMITTER DETAILS SHOWED EVERYTHING WAS GREEN AND THE INTERFERENCE VALUE ON THE STRAIGHT SUCTION WAS 1.2. WHEN THE SURGEON INSERTED SUCTION, THE IMAGES DISAPPEARED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE FUSION NAVIGATION SYSTEM. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37478 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1