BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 23038896 · Received September 12, 2025

    Report

    Report Number
    1723170-2025-03212
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 11, 2025
    Report Date
    September 12, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    UDI-DI
    00763000272739
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: H3, H6; A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE CAMERA WAS REPLACED AND THE SYSTEM THEN PASSED TESTING. CODES B01, C08, AND D02 ARE APPLICABLE TO THIS ANALYSIS. THE CAMERA, LOT NUMBER: P903748, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE RETURNED PSU CONTAINED SCRATCHES ON THE HOUSING & LENSES. A CHECK OF THE EVENT LOG REVEALED INTERMITTENT FIRMWARE INCOMPATIBILITY DATING BACK TO (B)(6) 2021 AND AN ILLUMINATOR CURRENT ERROR, DATING BACK TO NOVEMBER 2024. THERE WAS ALSO A BATTERY VOLTAGE LOW MESSAGE ALONG WITH BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED MESSAGES. THE PSU FAILED AN ACCURACY TEST (AAK) AT .702MM WITH A PASSING THRESHOLD OF .250MM. THIS PSU HAD NOT BEEN PREVIOUSLY RETURNED FOR A FAILURE. 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 SYSTEM DISPLAYED A LOCALIZER NOT CONNECTED MESSAGE. THE NETWORK DEVICE INTERFACE (NDI) TOOLBOX WAS CHECKED, BUT FOUND ALL THE STATUSES WERE LISTED AS A QUESTION MARK. TECHNICAL SERVICES (TS) INFORMED THE REPRESENTATIVE THAT ADDITIONAL TROUBLESHOOTING WOULD BE NEEDED WITH THE CAMERA CART TO DETERMINE THE ROOT CAUSE. ON 2025-8-14 ADDITIONAL TROUBLESHOOTING WAS PERFORMED. IT WAS REPORTED THAT THE NDITOOLBOX HAD A BOX AROUND BUMP DETECTED AND THE TEMPERATURE EXCEEDED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170628 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665 00763000272739

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown "SEE H11...."