BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 22081183 · Received May 23, 2025

    Report

    Report Number
    1723170-2025-02072
    Event Type
    Malfunction
    Date Received
    May 23, 2025
    Date of Event
    May 12, 2025
    Report Date
    May 23, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00763000272739
    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 REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: PRODUCT ID: 9735821R (SERIAL: UNKNOWN). H3, H6) THE SYSTEM WAS SERVICED IN THE FIELD. IN SUMMARY, THE COMPLAINT WAS CONFIRMED. THE COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS) BATTERY WENT BAD AND THERE WAS A LOCALIZER FAULTED. THE CAMERA WAS REPLACED TO RESOLVE. CODES B01, C02, C08, AND D02 ARE APPLICABLE.  H6) MULTIPLE ANNEX A CODES WERE APPLIED TO CAPTURE THIS EVENT. A1102 CAPTURES THE LOCALIZER FAULTED AND SCU CONNECTION ERROR WHILE A05 CAPTURES THE NON-FUNCTIONAL CAMERA. 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 DISPLAYED A LOCALIZER FAULTED ERROR, AND THE SITE SWITCHED TO A DIFFERENT CAMERA CART BEFORE THE PATIENT WAS PRESENT. THE MANUFACTURER REPRESENTATIVE WALKED THE REPRESENTATIVE THROUGH THE NETWORK DEVICE INTERFACE (NDI) TOOLBOX AND IDENTIFIED THAT THE BUMP STATUS AND INTERNAL TEMPERATURE WERE TRIPPED ON THE CAMERA, ALONG WITH AN SCU CONNECTION FAILURE ERROR. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2366590 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00763000272739

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown