BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION¿ ENT NAVIGATION SYSTEM

    MDR report key: 8723661 · Received June 21, 2019

    Report

    Report Number
    1723170-2019-03738
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    March 28, 2018
    Report Date
    June 21, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994380005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE SYSTEM PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. 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 DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE SURGEON FELT INACCURATE BY APPROXIMATELY 10 MM. THE SITE REPORTED THAT THE TOP OF THE PATIENT'S HEAD WAS MISSING AND THERE WASN'T SUFFICIENT REAL ESTATE TO TRACE EFFECTIVELY. THE SURGEON DID NOT PERFORM POINT MERGE. THERE WAS NO KNOWN IMPACT ON PATIENT OUTCOME. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515827 FUSION¿ ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733560XOM 00613994380005

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR