BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 22927027 · Received August 29, 2025

    Report

    Report Number
    1723170-2025-03106
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    August 6, 2025
    Report Date
    August 29, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    UDI-DI
    00763000272739
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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: 9 735821R, LOT #: P903403, UDI#: (B)(4). H3, H6) A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. IT WAS REPORTED THE CAMERA/POSITIONING SENSOR UNIT (PSU) WAS REPLACED. THE 9735821R PSU WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. 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. THERE WAS A BATTERY VOLTAGE LOW MESSAGE ALONG WITH BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED. THE PSU FAILED AN ACCURACY TEST (AAK) AT .663MM 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 SYSTEM SHOWED AN OPTICAL LOCALIZER FAULTED MESSAGE. THE CAMERA HAD A GREEN AND AMBER LIGHT ILLUMINATED. THE CLINICAL CONSULTANT (CC) CHECKED THE NETWORK DEVICE INTERFACE (NDI) TOOLBOX AND FOUND: BUMP DETECTOR BATTERY FAULT, RETURN FOR SERVICE AND BUMP DETECTED. ACCURACY ASSESSMENT RECOMMENDED. AND STORAGE TEMPERATURE EXCEEDED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2025379 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665 00763000272739

    Patients

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