BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 23498789 · Received November 7, 2025

    Report

    Report Number
    1723170-2025-03679
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    October 17, 2025
    Report Date
    November 18, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    UDI-DI
    00763000272739
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 735821R, SERIAL/LOT #: -, UBD: , UDI#: H3, H6; THE CAMERA, LOT NUMBER: P902977, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE RETURNED PSU HAD SCRATCHES ON THE HOUSING AND LENSES. A CHECK OF THE EVENT LOG SHOWED INTERMITTENT FIRMWARE INCOMPATIBILITY DATING BACK TO DEC 2019, AND INTERMITTENT ILLUMINATOR CURRENT LOW DATING BACK TO FEB 2020. THERE WAS A BATTERY VOLTAGE LOW MESSAGE ALONG WITH BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED. THE PSU FAILED AN ACCURACY TEST (AAK) AT .576MM WITH A PASSING THRESHOLD OF .250MM. THIS PSU HAD NOT BEEN PREVIOUSLY RETURNED FOR A FAILURE. CODES B01, C02, 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.

    Additional Manufacturer Narrative · 0

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. HARDWARE WAS REPLACED. CODES B01, C02, 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 WHILE SETTING UP FOR A CASE, THE SITE'S INSTRUMENTS WERE NOT BEING TRACKED WHEN HELD IN FRONT OF THE CAMERA AND THE SYSTEM WAS DISPLAYING LOCALIZER NOT CONNECTED. THE SITE SWITCHED TO ANOTHER SYSTEM, AND THE SAME ISSUE OCCURRED. THERE WAS NO PATIENT INVOLVEMENT. ON 2025-OCT-17 IUD (REP): ADDITIONAL INFORMATION WAS RECEIVED. A MANUFACTURER REPRESENTATIVE (REP) VISITED THE SITE AND FOUND THAT THE MESSAGE DISPLAYED ON THIS SYSTEM WAS LOCALIZER FAULTED. TECHNICAL SERVICES (TS) HAD THE REP CHECK NDITOOLBOX. THE FOLLOWING FINDINGS WERE OBSERVED: BUMP DETECTOR BATTERY FAULT, BUMP DETECTED, AND STORAGE TEMPERATURE EXCEEDED. THE INTERNAL POSITIONING SENSOR UNIT (PSU) BATTERY HAS LIKELY FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1873734 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665 00763000272739

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown