BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 20544633 · Received October 28, 2024

    Report

    Report Number
    1723170-2024-03314
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    October 23, 2024
    Report Date
    January 30, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE CAMERA (PRODUCT: CAMERA REFURB 9735821R VEGA BASE S8 SVC, SERIAL/LOT: P901059) WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND NO FAILURE. H6: ADDITIONAL REVIEW INDICATED CODE C02 IS NO LONGER APPLICABLE TO THE EVENT. CODES D02, B01, C08 APPLY TO THE SYSTEM (PRODUCT: SURGN CART 9735665 STEALTH S8 PREMIUM, SERIAL/LOT: (B)(6) AND TO ONE OF THE CAMERAS (PRODUCT: CAMERA 9735821 VEGA BASE S8 SVC, SERIAL/LOT: P901711). CODES D14, B01, C19 APPLY TO THE OTHER CAMERA (PRODUCT: CAMERA REFURB 9735821R VEGA BASE S8 SVC, SERIAL/LOT: P901059). 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

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735821, SERIAL/LOT #: UNKNOWN AND PRODUCT ID: 9735821R, SERIAL/LOT #: UNKNOWN H3) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. CODES: B17, C20, D15. 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

    H3: A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. IT WAS REPORTED THAT CAMERA WAS REPLACED. THE NAVIGATION S YSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE CAMERA (PRODUCT: CAMERA 9735821 VEGA BASE S8 SVC, SERIAL/LOT: (B)(6) WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND THAT THERE WAS A DAMAGED CAMERA OR SENSOR CONTROL UNIT (SCU). THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. H6: ADDITIONAL REVIEW INDICATED CODES D15, B17, C20 ARE NO LONGER APPLICABLE TO THE EVENT. 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 "LOCALIZER FAULTED". THE FIELD REPRESENTATIVE (REP) ACCESSED THE NDI TOOLBOX AND FOUND THE BUMP AND STORAGE TEMPERATURE FAULTS WERE TRIGGERED. THE SYSTEM DISPLAYED "BUMP DETECTOR BATTERY FAULT...RETURN FOR SERVICE." NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166803 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown