BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION¿ ENT NAVIGATION SYSTEM

    MDR report key: 8663700 · Received June 3, 2019

    Report

    Report Number
    1723170-2019-02870
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Report Date
    June 3, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. A SOFTWARE INVESTIGATION ANALYSIS WAS INITIATED TO DETERMINE THE PROBABLE CAUSE OF THE ISSUE THROUGH PRODUCT AND/OR VERSION CONFIRMATION. ANALYSIS FOUND THAT THE SITE WAS UNABLE TO REGISTER THE PATIENT BECAUSE THEY WERE TRYING TO USE THE NIPT BUT DID NOT HAVE IT LOADED TO THE SOFTWARE. ANALYSIS FOUND THAT THE SOFTWARE FUNCTIONED AS DESIGNED. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE SYSTEM PERFORMED AS INTENDED. THE SYSTEM PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: SOFTWARE, 9733467, FUSION ENT APP, 9733467. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO REGISTER THE PATIENT USING TRACER DURING HIS FESS CASE. HE TRIED NUMEROUS TIMES BUT WAS UNABLE TO PASS AND EVENTUALLY ABORTED USE OF NAVIGATION. IT WAS NOTED THAT THE SITE RETRIEVES THEIR EXAMS USING DICOM QR. THIS OCCURRED INTRA/PERI-OPERATIVELY WITH LESS THAN ONE HOUR DELAY TO SURGICAL TIME. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458063 FUSION¿ ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733560XOM

    Patients

    Seq Age Sex Outcome Treatment
    1