BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION

    MDR report key: 8208666 · Received January 2, 2019

    Report

    Report Number
    1723170-2019-00017
    Event Type
    Malfunction
    Date Received
    January 2, 2019
    Date of Event
    December 7, 2018
    Report Date
    January 2, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE SYSTEM CONTROL UNIT (SCU) NEEDED TO REPLACED. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE SCU WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND THAT WHEN CONNECTED TO A KNOWN GOOD SYSTEM, THE RETURNED SCU WOULD NOT POWER ON. THE EVENT LOG SHOWED A SCU CONNECTION FAILURE. ANALYSIS FOUND THAT THE REPORTED EVENT WAS RELATED TO A ELECTRICAL ISSUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE AMBER FAULT LIGHT ON THE CAMERA OF THE NAVIGATION SYSTEM WAS ILLUMINATED. IT WAS REPORTED THAT THE NAVIGATION SYSTEM TRACKED INSTRUMENTS WITHOUT ISSUE. THE NDI CONFIGURATION UTILITY WAS OPENED AND THERE WAS A CONNECTION FAULT WITH THE POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU). THE CONNECTION TO THE ROUTER WAS FULLY SEATED INTO L5. IT WAS NOTED THAT THE HOSTNAME/IPS ON THE ROUTER, WIFI AND SCU WERE ALL RED. UNPLUGGING THE ETHERNET CONNECTION ONLY DISPLAYED THE UNAVAILABLE STATUS BUT DID NOT UPDATE THE HOST NAME OR IPS TO BE UNAVAILABLE. THE NAVIGATION SYSTEM WAS ABLE TO PING THE IP ADDRESS ON BOTH THE FIREWALL AND ENDPOINT, BUT NOT THE SCU. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827 STEALTHSTATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1