BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 23020325 · Received September 10, 2025

    Report

    Report Number
    1723170-2025-03192
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    August 25, 2025
    Report Date
    September 10, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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 #: P901360, UDI#: (B)(4). H3, H6) A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. IT WAS REPORTED THAT THE CAMERA WAS REPLACED. THE 9735821R CAMERA / POSITIONING SENSOR UNIT (PSU) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RETURNED PSU HAD SCRATCHES ON THE HOUSING AND LENSES. EVENT LOGS REPORT INTERMITTENT FIRMWARE INCOMPATIBILITY AND INTERMITTENT FAULTS INDICATING ILLUMINATOR VOLTAGE MEASURED LOWER THAN RECOMMENDED OPERATING VOLTAGE. THERE WAS A BATTERY VOLTAGE LOW MESSAGE, ALONG WITH BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED ALERTS. THE PSU FAILED AN ACCURACY TEST (AAK) AT .570MM, WITH A PASSING THRESHOLD OF 0.250MM. 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 WHILE SETTING UP FOR A CASE, THE SITE BOOTED THE SYSTEM AND NOTICED THE "LOCALIZER NOT CONNECTED" MESSAGE SHOWN ON SCREEN. THE SITE SWITCHED TO A DIFFERENT SYSTEM. THERE WAS NO PATIENT INVOLVEMENT. WHILE TROUBLESHOOTING THE CLINICAL SPECIALIST (CS) OPENED NETWORK DEVICEINTERFACE (NDI) TOOLBOX AND FOUND: "BUMP DETECTOR BATTERY FAULT. RETURN FOR SERVICE. BUMP DETECTED. ACCURACY ASSESSMENT RECOMMENDED. STORAGE TEMPERATURE EXCEEDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2048671 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665 00643169722187

    Patients

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