BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 22842212 · Received August 19, 2025

    Report

    Report Number
    1723170-2025-03008
    Event Type
    Malfunction
    Date Received
    August 19, 2025
    Date of Event
    July 21, 2025
    Report Date
    November 3, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    UDI-DI
    00763000272739
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: (B)(4) , LOT #: P902546, , UDI#: (B)(4) H3, H6: A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE CAMERA WAS REPLACED AND THE SYSTEM PERFORMED AS INTENDED. CODES B01, C08, AND D02 ARE APPLICABLE TO THIS ANALYSIS. H3, H6: THE CAMERA WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THROUGH FUNCTIONAL TESTING, VISUAL/PHYSICAL EXAMINATION, AND PROCE DURALIZED DEVICE TESTING, THE CAMERA WAS FOUND TO HAVE 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 REPORTED EVENT WAS DUPLICATED BY MEDTRONIC PERSONNEL. CODES B01, C02, AND D02 ARE APPLIC ABLE 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.

    Additional Manufacturer Narrative · 0

    H2: ADDITIONAL INFORMATION WAS RECEIVED. A VENDOR ANALYSIS CONFIRMED THE BATTERY TO BE FAULTED. THE FAULTED BATTERY AND ITS ENCLOSURE WERE REPLACED AND THE COMPONENT THEN FUNCTIONED AS INTENDED. 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 SITE EXPERIENCED A "LOCALIZER FAULTED" ERROR. THE CAMERA WAS NOT CONNECTED AND AN AMBER LIGHT WAS ON. THE NETWORK DEVICE INTERFACE (NDI) TOOLBOX SHOWED BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284633 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665 00763000272739

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown