BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 22338022 · Received June 26, 2025

    Report

    Report Number
    1723170-2025-02488
    Event Type
    Malfunction
    Date Received
    June 26, 2025
    Date of Event
    March 26, 2025
    Report Date
    June 26, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A12, A1102: LOCALIZER NOT CONNECTED D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735821, SERIAL/LOT #: P905061, UBD: UNKNOWN, UDI#: UNKNOWN F1906: USE OF NAVIGATION ABANDONED F26: NO DELAY G2: THIS EVENT OCCURRED IN JAPAN, SEE SECTION E. H3, H6: THE SYSTEM WAS SERVICED IN THE FIELD. HARDWARE PARTS WERE REPLACED. CODES B01, C13, AND D02 ARE APPLICABLE. H3, H6: THE RETURNED PSU WAS ANALYZED. IT HAD SCRATCHES ON THE HOUSING AND LENSES. A CHECK OF THE EVENT LOG SHOWED INTERMITTENT ILLUMINATOR CURRENT LOW, AND INTERMITTENT FIRMWARE INCOMPATIBILITY. THERE WAS A BATTERY VOLTAGE LOW MESSAGE ALONG WITH BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED. THE PSU FAILED AN ACCURACY TEST (AAK) AT .463MM WITH A PASSING THRESHOLD OF .250MM. CODES B01, 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.

    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 THE SYSTEM WAS UNABLE TO RECOGNIZE THE CAMERA WITH A LOCALIZER NOT CONNECTED. THE USE OF NAVIGATION WAS ABANDONED, AND THE OPERATION WAS CONTINUED. A REPLACEMENT OF THE REPLACEMENT PUMP WAS PERFORMED. THE SENSOR BATTERY ERROR WAS DETECTED IN THE POSITIONING SENSOR UNIT (PSU) STATUS. THERE WAS NO SURGICAL DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201227 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665

    Patients

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