BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 23077413 · Received September 17, 2025

    Report

    Report Number
    1723170-2025-03257
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    August 27, 2025
    Report Date
    December 4, 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: ADDITIONAL INFORMATION WAS RECEIVED. A VENDOR ANALYSIS CONFIRMED THE BATTERY FAULT. THE BATTERY, ENCLOSURE, AND IR WINDOW WERE REPLACED AND THE COMPONENT FUNCTIONED AS INTENDED. 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: 9735821R, SERIAL/LOT #: (B)(6), UDI#: (B)(4) H6: A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. HARDWARE WAS REPLACED. CODES B01, C02, C08, AND D02 ARE A PPLICABLE TO THIS ANALYSIS. H6: THE CAMERA, LOT NUMBER: P902410, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE RETURNED POSITIONING SENSOR UNIT (PSU) H AD SCRATCHES ON THE HOUSING AND LENSES. EVENT LOGS REPORT INTERMITTENT FIRMWARE INCOMPATIBILITY, 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 .429MM, WITH A PASSING THRESHOLD OF 0.250MM. THE REPORTED EVENT COULD BE DUPLICATED BY MEDTRONIC PERSONNEL. CODES B01, C02, C08, AND D02 ARE APPLICABLE TO THIS ANALYSIS. H6: A05 - LOCALIZER FAULTED A1102 - ERROR MESSAGE 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 DISPLAYED A 'LOCALIZER FAULTED' NOTIFICATION. ADDITIONAL FAULTS WERE IDENTIFIED, INCLUDING BUMP STATUS AND INTERNAL TEMPERATURE STATUS FAULTS. TECHNICAL SERVICES INSTRUCTED THE CALLER TO ACCESS NAVIGATION SYSTEM ADMIN AND NDI TOOLBOX, WHERE THE FAULTS WERE CONFIRMED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2552517 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665 00643169722187

    Patients

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