BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 23100734 · Received September 19, 2025

    Report

    Report Number
    1723170-2025-03278
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    July 7, 2025
    Report Date
    September 19, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    UDI-DI
    00763000198626
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: 9735821R, SERIAL/LOT #: (B)(6), UDI#: (B)(4).G2: FOREIGN COUNTRY - JAPAN. H3, H6: MULTIPLE FDD/ANNEX A CODES WERE REPORTED. A05 WAS CODED FOR LOCALIZER FAULTED. A1102 WAS CODED FOR "LOCALIZER FAULTED" WAS DISPLAYED. THE SYSTEM WAS SERVICED IN THE FIELD BY A MEDTRONIC REPRESENTATIVE. THE CAMERA WAS REPLACED TO RESOLVE THE ISSUE. CODES B01, C08, AND D02 ARE APPLICABLE. THE 9735821R CAMERA, LOT P904282 WAS RETURNED FOR EVALUATION. ANALYSIS FOUND AN ELECTRICAL FAILURE. THE RETURNED POSITION SENSOR UNIT (PSU) HAD SCRATCHES ON THE HOUSING AND LENSES. EVENT LOGS REPORTED 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 .528MM, WITH A PASSING THRESHOLD OF 0.250MM. CODES B01, C02, 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. 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 "LOCALIZER FAULTED" WAS DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955011 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665 00763000198626

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown