BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 3951140 · Received July 22, 2014

    Report

    Report Number
    1723170-2014-00782
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    February 1, 2013
    Report Date
    February 1, 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

    THE DECISION TO FILE THIS REPORT WAS DERIVED FROM FINDINGS OF AN INTERNAL MANUFACTURER CAPA ADDRESSING DELAY OF THERAPY TO THE PATIENT.SOFTWARE INVESTIGATION WAS COMPLETED. INVESTIGATION FOUND THAT BY UNINSTALLING AND REINSTALLING THE SOFTWARE, THE IMAGE SETTINGS WERE DELETED. THE SITE WAS INSTRUCTED TO UPDATE THEIR SETTINGS TO IMPROVE THE IMPORT OF THE EXAMS. SOFTWARE IS FUNCTIONING AS DESIGNED.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REPRESENTATIVE REPORTED THAT, DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE COMPUTED TOMOGRAPHY (CT) IMAGES WERE TRANSFERRING WITH BLACK AND WHITE SWITCHED; BONE APPEARED BLACK AND THE BACKGROUND WAS WHITE. IN TROUBLESHOOTING, THE MEDTRONIC REPRESENTATIVE WAS INFORMED THE SOFTWARE WAS UNINSTALLED AND RE-INSTALLED EARLIER THAT DAY. THE MEDTRONIC REPRESENTATIVE INSTRUCTED THE SITE TO ADJUST THE SOFTWARE IMAGE SETTINGS, DELETE THE PATIENT EXAM, EXIT AND RE-ENTER THE PROGRAM, THEN RELOAD THE EXAM. AFTER THESE CHANGES WERE COMPLETED, THE IMAGES LOADED CORRECTLY. THE SURGEON CONTINUED AND COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME. THE SITE EXPERIENCED AN HOUR DELAY TO START OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427983 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR