BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 23659505 · Received November 26, 2025

    Report

    Report Number
    1723170-2025-03821
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 17, 2025
    Report Date
    November 26, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: 9735821R, SERIAL/LOT #: (B)(6), UDI#: (B)(4). WO: H3: A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE CAMERA WAS REPLACED. THE SYSTEM THEN FUNCTIONED AS IN TENDED. H6: CODES B01, C08, AND D02 ARE APPLICABLE TO THE SYSTEM CHECKOUT. HW ANALYSIS: H3: THE CAMERA, LOT NUMBER: P902009, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE RETURNED POSITIONING SENSOR UNIT (PSU) CONTAINED SCRATCHES ON THE HOUSING AND LENSES. A CHECK OF THE EVENT LOG REVEALED INTERMITTENT FIRMWARE INCOMPATIBILITY. 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 .559MM WITH A PASSING THRESHOLD OF .250MM. H6: CODES B01, C02, C08 AND D02 ARE APPLICABLE TO THIS ANALYSIS. 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 PROMPTED A LOCALIZER FAULTED MESSAGE WHILE THE SPINE TEAM WAS SETTING UP FOR A CASE. NO PATIENT PRESENT. TROUBLESHOOTING WAS PERFORMED. TECHNICAL SERVICES (TS) HAD THE FIELD REPRESENTATIVE (REP) OPEN NDI TOOLBOX AND FOUND THE FOLLOWING ERROR MESSAGES ON THE SCREEN, "BUMP DETECTOR BATTERY FAULT. RETURN FOR SERVICE.", "BUMP DETECTED. ACCURACY ASSESSMENT RECOMMENDED." AND "STORAGE TEMPERATURE EXCEEDED.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2538636 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11