BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 22814555 · Received August 15, 2025

    Report

    Report Number
    1723170-2025-02985
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Date of Event
    July 15, 2025
    Report Date
    August 15, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    UDI-DI
    00643169838895
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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, LOT #: P903331, UDI#: (B)(4). H3, H6) A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. IT WAS REPORTED THE POSITIONING SENSOR UNIT (P SU)/CAMERA WAS REPLACED. THE 9735821R CAMERA WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS REPORTED THAT THE RETURNED PSU HAD SCRATCHES ON THE HOUSING AND LENSES. A CHECK OF THE EVENT LOG SHOWED INTERMITTENT FIRMWARE INCOMPATIBILITY AND INTERMITTENT ILLUMINATOR CURRENT LOW, AND INTERMITTENT ILLUMINATOR VOLTAGE LOW. THERE WAS A BATTERY VOLTAGE LOW MESSAGE ALONG WITH BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED. THE PSU FAILED AN ACCURACY TEST (AAK) AT .835MM WITH A PASSING THRESHOLD OF .250MM. CODES B01, C08, AND D02 ARE APPLICABLE. 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 SITE INFORMED OF A SYSTEM LOCALIZER FAULTED. THE MANUFACTURER REPRESENTATIVE (REP) ATTENDED THE SITE AND CONFIRMED THROUGH NETWORK DEVICE INTERFACE (NDI) TOOLBOX FOR LOCALIZER TO BE REPORTING: "BUMP DETECTOR BATTERY FAULT. RETURN FOR SERVICE. BUMP DETECTED. ACCURACY ASSESSMENT RECOMMENDED. STORAGE TEMPERATURE EXCEEDED." THE REP ORDERED A NEW CAMERA. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225241 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665 00643169838895

    Patients

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