BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION¿ ENT NAVIGATION SYSTEM

    MDR report key: 8552029 · Received April 25, 2019

    Report

    Report Number
    1723170-2019-01993
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Date of Event
    April 19, 2019
    Report Date
    May 22, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169518452
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE REPORTED ISSUE COULD NOT BE REPLICATED AND THE NAVIGATION SYSTEM FUNCTIONED AS DESIGNED. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A SOFTWARE ANALYSIS WAS INITIATED TO DETERMINE THE PROBABLE CAUSE. ANALYSIS FOUND ARCHIVE PRESENT IN FDR WAS REVIEWED AND CONFIRMED TO ONLY HAVE 5 SLICES IN THE DATA FOLDERS FOR THE EXAMS. THIS CORRELATES TO THE ISSUES FOUND BY (B)(4) WHEN ON SITE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT, WHEN LOADING A COMPUTED TOMOGRAPHY (CT) IMAGE ONTO THE NAVIGATION SYSTEM FROM A NEWTOM CGI EVO CT SCANNER, THE UNIVERSAL SERIAL BUS (USB) DEVICE USED COULD NOT BE LOADED ONTO THE NAVIGATION SYSTEM. A SECOND NAVIGATION SYSTEM AT THE SITE COULD LOAD THE EXAM WITHOUT ISSUE. A SECOND USB WAS BURNED WITHOUT RESOLUTION. THREE CDS WERE BURNED WITHOUT RESOLUTION. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE NAVIGATION SYSTEM. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF MORE THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341768 FUSION¿ ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733560XOM 00643169518452

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR