BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 23327675 · Received October 17, 2025

    Report

    Report Number
    1723170-2025-03485
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Date of Event
    August 18, 2025
    Report Date
    October 17, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    UDI-DI
    00763000359881
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9 735820, SERIAL/LOT #: (B)(6), UBD: , UDI#: WORK ORDER COMPLETED: H3, H6) A MANUFACTURER REPRESENTATIVE (REP) WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. IT WAS REPORTED THAT THE SYSTEM CONTROL UNIT (SCU) WAS REPLACED TO RESOLVE THE ISSUE. CODES B01, C08 AND D02 ARE APPLICABLE. H3, H6: ANALYSIS WAS PERFORMED FOR PRODUCT: 9735820, LOT NUMBER: T906155. IT WAS REPORTED THAT THE RETURNED SYSTEM CONTROL UNIT (SCU) WOULD NOT COMMUNICATE WHEN POWERED UP AND CONNECTED TO A KNOWN GOOD SYSTEM. IT WAS NOT ABLE TO VIEW THE EVENT LOG. CODES B01, C08 AND D02 ARE ALSO APPLICABLE TO THIS ANALYSIS. A13: APPLICABLE TO THE SCU CONNECTION ERROR. A1102: APPLICABLE TO THE SCU CONNECTION ERROR MESSAGE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE MANUFACTURING REPRESENTATIVE (REP) HAD DIFFICULTY CONNECTING A SCOPE TO THE SYSTEM. THE REP CHECKED THE CAMERA AND FOUND THAT THERE WAS AN AMBER LIGHT ON THE CAMERA. THE REP PLACED SECONDARY SYSTEMS SYSTEM CONTROL UNIT (SCU) INTO THE 'BAD' SYSTEM, AND SCU LIGHT WENT GREEN WHICH CONFIRMED THAT THE INTERNAL CABLING IN THE SYSTEM WAS FUNCTIONING AS INTENDED AND THE SCU IS AT FAULT. IT WAS REPORTED THAT WHEN PLUGGING THE SYSTEM'S SCU INTO ANOTHER STEALTH SYSTEM, THE SCU LIGHT CHANGED FROM FLASHING AMBER TO GREEN AND CONNECTION WAS ESTABLISHED. IT WAS NOTED THAT THE REP WAS SUSPECTING A FAULTY SCU. TECHNICAL SERVICES (TS) HAD THE REP CHECK THE NDI TOOLBOX AND FOUND AN ALERT THAT READ "SCU CONNECTION ERROR." THE REP CHECKED THE SELF TEST AND FOUND THAT THE INTERNAL COMPONENT FIRMWARE WAS LISTED AS "UNKNOWN" FOR THE SCU. THE REP TOOK OFF THE BACK OF THE SYSTEM AND FOUND A SOLID GREEN AND FLASHING AMBER LIGHT ON THE SCU. AFTER R ESEATING THE ETHERNET CABLE, REBOOTING THE SYSTEM, SWAPPING THE ETHERNET TO LAN 6 ON THE ROUTER, AND UNPLUGGING THE ETHERNET COMPLETELY THE ISSUE HAD PERSISTED. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323841 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665 00763000359881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown