BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 22952288 · Received September 3, 2025

    Report

    Report Number
    1723170-2025-03116
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    August 5, 2025
    Report Date
    September 2, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 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). WORK ORDER COMPLETED: H3, H6) A MANUFACTURER REPRESENTATIVE (REP) 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. H3, H6: ANALYSIS WAS PERFORMED FOR PRODUCT: 9735821R, LOT NUMBER: P902429. IT WAS REPORTED THAT THE RETURNED POSITIONING SENSOR UNIT (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 .683MM WITH A PASSING THRESHOLD OF .250MM. CODES B01, C08 AND D02 ARE ALSO APPLICABLE TO THIS ANALYSIS. A05: APPLICABLE TO LOCALIZER FAULTED. A1102: APPLICABLE TO THE 'LOCALIZER FAULTED' 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 INTRA-OPERATIVELY DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SYSTEM DISPLAYED 'LOCALIZER FAULTED' UPON BOOT UP OF THE SYSTEM. A MANUFACTURER REPRESENTATIVE (REP) FORWARDED A PHOTO OF NETWORK DEVICE INTERFACE (NDI) TOOLBOX TO TECHNICAL SERVICES (TS). TS DETERMINED THAT THIS WAS CAUSED BY A DEAD COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS) BATTERY IN THE CAMERA. NDI TOOLBOX ALSO SHOWED 'BUMP DETECTED' AND 'STORAGE TEMPERATURE EXCEEDED'. IT WAS REPORTED THERE WAS A DELAY OF APPROXIMATELY 2 HOURS. THE SITE ENDED UP HAVING A NAVIGATION SYSTEM FROM ANOTHER HOSPITAL IN THE SYSTEM TRUCKED IN. SO THEY WAITED FOR THAT SYSTEM AND THEN COMPLETED THE CASE. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS NO IMPACT TO PATIENT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1734838 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown