BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 22090304 · Received May 27, 2025

    Report

    Report Number
    1723170-2025-02087
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    May 19, 2025
    Report Date
    September 12, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    UDI-DI
    00763000272739
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H2 ADDITIONAL INFORMATION: UPDATED B5. H2 CORRECTION, H3, H6: THE SYSTEM WAS SERVICED IN THE FIELD BY A MEDTRONIC REPRESENTATIVE. HARDWARE PARTS WERE REPLACED. AFTERWARDS, THE SYSTEM WAS PERFORMING AS INTENDED. CODES B01, C08, AND D02 ARE APPLICABLE. H2 DEVICE EVALUATION, H3, H6: THE 9735821R CAMERA LOT P903533 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 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 .803 MM WITH A PASSING THRESHOLD OF .250 MM. 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. 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 REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: PRODUCT ID: 9735762, SOFTWARE VERSION: 2.1.0 AND PRODUCT ID: 9735821R, SERIAL/LOT: UNKNOWN. MULTIPLE ANNEX A CODES WERE APPLIED TO CAPTURE THIS EVENT. A1102 CAPTURES THE ERROR MESSAGE WHILE A05 CAPTURES THE CAMERA FUNCTIONALITY ISSUES. H3, H6) NO PARTS HAVE RETURNED TO THE MANUFACTURER FOR ANALYSIS. CODES B17, C20, AND D15 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.

    Additional Manufacturer Narrative · 0

    H6: A SOFTWARE INVESTIGATION ANALYSIS WAS INITIATED TO DETERMINE THE PROBABLE CAUSE OF THE ISSUE THROUGH LOG ANALYSIS. ANALYSIS FOUND THAT THE REPORTED ISSUE WAS NOT CAUSE BY THE SOFTWARE. ANALYSIS FOUND THAT THE SOFTWARE FUNCTIONED AS DESIGNED. CODES B01, C19, D14 ARE APPLICABLE TO THIS ANALYSIS. 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

    IT WAS REPORTED THAT THE EVENT WAS OBSERVED PREOPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING A SACROILIAC AND THORACOLUMBAR SURGICAL PROCEDURE, A LOCALIZER ERROR OCCURRED WITH THE NAVIGATION SYSTEM. ADDITIONALLY, THERE WERE INTERNAL TEMPERATURE AND BUMP STATUS FAULTS, AND THE COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS) BATTERY IN THE CAMERA HAD DIED. TROUBLESHOOTING STEPS INCLUDED A SUGGESTION TO SWAP CAMERA CARTS WITH A KNOWN WORKING CAMERA CART. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332538 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665 00763000272739

    Patients

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