BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 23408132 · Received October 28, 2025

    Report

    Report Number
    1723170-2025-03578
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    September 25, 2025
    Report Date
    October 28, 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
    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 CAMERA, SERIAL/LOT #: (B)(6): G2: FOREIGN COUNTRY - JAPAN H3, H6: THE 9735821R CAMERA, LOT P901573 WAS RETURNED FOR EVALUATION. ANALYSIS FOUND AN ELECTRICAL FAILURE. THE RETURNED POSITION SENSOR UNIT (PSU) HAD SCRATCHES ON THE HOUSING. A CHECK OF THE EVENT LOG DID NOT SHOW ANY ADVERSE EVENTS. THE PSU FAILED AN ACCURACY TEST (AAK) AT .386MM WITH A PASSING THRESHOLD OF .250MM. CODES B01, C02, 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 THERE WAS A FAILURE TO RECOGNIZE THE POWER SUPPLY UNIT. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS A FAILURE TO RECOGNIZE THE POSITION SENSOR UNIT (PSU)/CAMERA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244233 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665 00763000198626

    Patients

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