BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 22874922 · Received August 22, 2025

    Report

    Report Number
    1723170-2025-03041
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    July 22, 2025
    Report Date
    September 5, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    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 735821R, SERIAL/LOT #: (B)(6): UDI#: (B)(4); PRODUCT ID: 9735821R, SERIAL/LOT #: (B)(6): UDI#: (B)(4). H3: A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT HARDWARE WAS REPLACED. THE NAVIGATION SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. H3: HARDWARE ANALYSIS WAS COMPLETED ON THE RETURNED POSITIONING SENSOR UNITS (PSU). THE RETURNED PSU LOT #: P900475 HAD SCRATCHES ON THE HOUSING. A CHECK OF THE EVENT LOG SHOWED TWO INSTANCES OF BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED WITH ERRONEOUS DATES; EVENTS USUALLY ASSOCIATED WITH A BATTERY FAILURE. THE PSU PASSED AN ACCURACY TEST (AAK) AT .076MM WITH A PASSING THRESHOLD OF .250MM. THE RETURNED POSITIONING SENSOR UNIT (PSU) LOT # P927935 HAD NO FAULTS OR FAILURES FOUND. IT HAD NORMAL TRACKING AND PASSED AN ACCURACY TEST (AAK) AT .105MM WITH A PASSING THRESHOLD OF .250MM. H6: B01, C04 AND D02 APPLY TO THE SYSTEM CHECKOUT AND CONCOMITANT PRODUCT ID 9735821R ; LOT # P900475. B01, C19 AND D14 APPLY TO CONCOMITANT PRODUCT ID 9735821R ; LOT # P927935 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

    H2) CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735821, SERIAL/LOT #: (B)(6):- H2-3) THE POSITIONING SENSOR UNIT (PSU) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AFTER FUNCTIONAL TESTING, PHYSICAL EXAMINATION, AND PROCEDURALIZED DEVICE TESTING, THE REPORTED ISSUE WAS CONFIRMED. THE RESULTS OF THE ANALYSIS CONCLUDED THAT THE PSU HAD ELECTRICAL FAILURE. THE PSU CONTAINED SCRATCHES ON THE HOUSING LENSES. A CHECK OF THE EVENT LOG REVEALED INTERMITTENT FIRMWARE INCOMPATIBILITY AND A ILLUMINATOR VOLTAGE ERROR. THERE WAS ALSO A BATTERY VOLTAGE LOW MESSAGE ALONG WITH BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED MESSAGES. CODES: B01, C02, D02 H2) PLEASE SEE SECTION D9 FOR WHEN THE DEVICE WAS AVAILABLE 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.

    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 DISPLAYING LOCALIZER FAULTED. THE REPRESENTATIVE CALLED TO REPORT THAT THE NEW CAMERA LEDS SENT TO THE SITE DID NOT ILLUMINATE WHEN THE SYSTEM WAS POWERED ON. WHEN ENTERING A MOCK PROCEDURE, THE MESSAGE "CAMERA NOT CONNECTED" APPEARED. THE REPRESENTATIVE ATTEMPTED TO RECONNECT THE CAMERA MULTIPLE TIMES WITHOUT SUCCESS. ULTIMATELY, SHE RECONNECTED THE OLD (FAULTED) CAMERA, WHICH POWERED ON IMMEDIATELY, AND THE LED LIGHT ILLUMINATED AS EXPECTED. THE REPRESENTATIVE WAS NOT ON SITE AT THE TIME OF THE CALL TO CHECK FOR POE CONNECTION. IT WAS REPORTED THIS LOCATION HAS THREE SYSTEMS, ALL INSTALLED IN 2017, AND THEY HAVE NOW SEEN MULTIPLE REPORTS OF CAMERA FAILURES ACROSS THEM. SPECIFICALLY, THIS SYSTEM HAD A CMOS BATTERY FAILURE LAST YEAR, WHICH RESULTED IN A FULL CAMERA REPLACEMENT. AS THE CMOS BATTERY ISSUES SHOULD NOT USUALLY RECUR WITHIN A YEAR, IT WAS RECOMMENDED TO THE REPRESENTATIVE TO CHECK FOR ANY UNDERLYING PATTERNS OR CONCERNS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2667527 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665 00643169722187

    Patients

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