BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 23418280 · Received October 29, 2025

    Report

    Report Number
    1723170-2025-03588
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    July 10, 2025
    Report Date
    October 29, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    UDI-DI
    00763000198626
    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

    CONTINUATION OF D10: 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). H3, H6: A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. HARDWARE WAS REPLACED. CODES B01, C02, C08, AND D02 ARE APPLICABLE TO THIS ANALYSIS. H3, H6: THE CAMERA, LOT NUMBER: P921873, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. A CHECK OF THE EVENT LOG SHOWED INTERMITTENT FIRMWARE INCOMPATIBILITY, AND INTERMITTENT SENSOR NOT FUNCTIONING. THE POSITIONING SENSOR UNIT (PSU) PASSED AN ACCURACY TEST (AAK) AT .166MM WITH A PASSING THRESHOLD OF .250MM. THE REPORTED EVENT COULD BE DUPLICATED BY MEDTRONIC PERSONNEL. CODES B01, C02, C08, AND D02 ARE APPLICABLE TO THIS ANALYSIS. H6: A05 - LOCALIZER FAULTED A1102 - ERROR MESSAGE A0709 - INSTRUMENTS STOPPED RECOGNIZING. 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 DEVICE SUDDENLY STOPPED RECOGNIZING THE REFERENCE AND PROBE DURING NAVIGATION USAGE. THE SYSTEM REBOOTED, BUT A LOCALIZER ERROR WAS DISPLAYED. AS RECOVERY WAS DIFFICULT, THE NAVIGATION WAS DISCONTINUED AND IT WAS HANDLED WITH A NON-MEDTRONIC IMAGING SYSTEM. THERE WAS A LESS THAN ONE HOUR SURGICAL DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME. ALL INSTRUMENTS USED IN THE OPTICAL SYSTEM WERE NOT RECOGNIZED, AND "LOCALIZER FAULTED" WAS DISPLAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2701663 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665 00763000198626

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown