BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 21901571 · Received April 24, 2025

    Report

    Report Number
    1723170-2025-01771
    Event Type
    Malfunction
    Date Received
    April 24, 2025
    Date of Event
    April 15, 2025
    Report Date
    May 20, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H2, H3) THE 9735821 CAMERA (LOT #: P903123) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RETURNED POSITIONING SENSOR UNIT (PSU) HAS SCRATCHES ON THE HOUSING. A CHECK OF THE EVENT LOG SHOWED INTERMITTENT FIRMWARE INCOMPATIBILITY. THERE WAS A BATTER VOLTAGE LOW MESSAGE ALONG WITH BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED. THE PSU PASSED AN ACCURACY TEST (AAK) AT .135MM WITH A PASSING THRESHOLD OF .250MM. 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.

    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 735821, SERIAL/LOT #: -, UBD: UNKNOWN, UDI#: UNKNOWN WORK ORDER COMPLETED: H3, H6) A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. IT WAS REPORTED THAT THE CAMERA WAS REPLACED TO RESOLVE THE ISSUE. CODES B01, C08 AND D02 ARE APPLICABLE. A05: APPLICABLE TO LOCALIZER FAULTED. A1102: APPLICABLE TO THE LOCALIZER FAULTED ERROR MESSAGE. A110201: APPLICABLE TO THE ERROR OCCURRING UPON BOOT UP. 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 WAS GIVING AN OPTICAL LOCALIZER FAULTED MESSAGE UPON BOOT UP. IT WAS CONFIRMED THAT AN AMBER LIGHT WAS ILLUMINATED ON THE CAMERA. TROUBLESHOOTING INVOLVED USING THE NETWORK DEVICE INTERFACE (NDI) TOOLBOX, AND IT WAS CONFIRMED THAT THE BUMP DETECTION AND INTERNAL TEMPERATURE STATUSES WERE MARKED WITH AN ALERT, AND THERE WAS A SUSPECTED INTERNAL COMPLEMENTARY METAL OXIDESEMICONDUCTOR (CMOS) BATTERY ISSUE. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1326164 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

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