BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 23975805 · Received January 6, 2026

    Report

    Report Number
    1723170-2026-00028
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 19, 2025
    Report Date
    January 6, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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). H3: A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE CAMERA WAS REPLACED. THE SYSTEM THEN FUNCTIONED AS INTENDED. H6: CODES B01, C08, AND D02 ARE APPLICABLE TO THE SYSTEM CHECKOUT. H3: THE CAMERA, LOT NUMBER: P904186, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE RETURNED POSITIONING SENSOR UNIT (PSU) CONTAINED SCRATCHES ON THE HOUSING AND LENSES. THE RIGHT LENS ALSO HAD A HOLE IN IT. A CHECK OF THE EVENT LOG REVEALED A BATTERY VOLTAGE LOW MESSAGE ALONG WITH BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED. THE PSU FAILED AN ACCURACY TEST (AAK) AT .604MM 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 A LOCALIZER FAULTED ERROR APPEARED UPON BOOT UP. TROUBLESHOOTING STEPS WERE PERFORMED. IN THE NETWORK DEVICE INTERFACE (NDI) TOOLBOX, IT SHOWED "BUMP DETECTOR BATTERY FAULT, BUMP DETECTED, AND STORAGE TEMPERATURE EXCEEDED STATUS MESSAGES. THE LIKELY CAUSE OF THE ISSUE WAS THE POSITIONING SENSOR UNIT (PSU). THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37457 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11