BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 24519259 · Received March 5, 2026

    Report

    Report Number
    1723170-2026-00351
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    February 27, 2026
    Report Date
    May 5, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    UDI-DI
    00763000272739
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H2: ADDITIONAL INFORMATION - THE CAMERA (PRODUCT ID: 9735821R) WAS RETURNED WITH THE LOT NUMBER: P904160. H2-H6: UPDATED ANNEX C (FDR) CODE, C02, WAS ADDED DUE TO THE ELECTRICAL FAILURE MODE IDENTIFIED IN THE CAMERA 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.

    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. PRODUCT ID: 960-991. (H3,H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. 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

    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. CODES B01, C08 AND D02 ARE APPLICABLE. H3, H6: ANALYSIS WAS ALSO PERFORMED ON THE CAMERA. IT WAS REPORTED THAT THE RETURNED POSITIONING SENSOR UNIT (PSU) HAD NO PHYSICAL DAMAGE. A CHECK OF THE EVENT LOG SHOWED SEVERAL INTERMITTENT INSTANCES OF SENSOR NOT FUNCTIONING. THE PSU PASSED AN ACCURACY TEST (AAK) AT .174MM WITH A PASSING THRESHOLD OF .250MM. THIS PSU HAD RECENTLY BEEN REPAIRED AFTER PROACTIVE REPLACEMENT. CODES B01, C08 AND D02 ARE ALSO 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 DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THEY WERE UNABLE TO TRACK ANY INSTRUMENTS WITH THE SYSTEM. THE SITE REBOOTED 2 TIMES: INSTRUMENTS BRIEFLY TRACKED GREEN AND THE INSTRUMENT STATUS THEN CHANGED TO AMBER. THE MANUFACTURING REPRESENTATIVE (REP) ALSO REPORTED THAT SITE WAS SEEING A "CAMERA FAILURE" MESSAGE UNDER THE "DETAILS TAB" BUT COULD NOT EXPLAIN FURTHER. CAMERA'S FAULT LIGHT WAS ON DURING THIS TIME AND WAS INTERMITTENTLY CLEARING WITH THE REBOOTS. THE REP CALLED TO REPORT THAT THE SITE WAS RECEIVING A LOCALIZER FAULTED MESSAGE AFTER 20MINUTES OF THE SYSTEM BEING TURNED ON, BUT THEN WOULD RESOLVE AFTER RESEATING THE INTERCONNECT CABLE. THEY NOTED THAT THE AMBER LIGHT WAS PRESENT BUT NO GREEN LIGHT (PER PSU MANUAL, THIS IS A NON-RECOVERABLE FAULT, DESPITE SITE STATING THE ISSUE COULD BE RESOLVED). RESEATING THE INTERCONNECT CABLE AND HARD REBOOTING THE SYSTEM CLEARED THE FAULT BUT REOCCURRED 1+ HOURS AFTER. THE SYSTEM STILL INTERMITTENTLY DISPLAYED LOCALIZER FAULT. THE NETWORK DEVICE INTERFACE (NDI) TOOLBOX SHOWED INTERMITTENTLY A HARDWARE FAULT - UNABLE TO INITIALIZE THE SYSTEM - IMAGE SENSOR FAULT. THE PSU EVENT LOG SHOWED REPEATED AND INTERMITTENT: "SENSOR NOT FUNCTIONING - TRY RESETTING THE SYSTEM" AND " SENSOR FUNCTIONING AGAIN" (NO FIRMWARE DETECTED ERRORS). THERE WERE INTERMITTENT SWITCHES BETWEEN GREEN AND AMBER PSU STATUS LIGHTS (NEVER AT THE SAME TIME). IT IS UNKNOWN IF THERE WAS ANY IMPACT ON PATIENT OUTCOME OR SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549561 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665 00763000272739

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown