BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 19973686 · Received August 13, 2024

    Report

    Report Number
    1723170-2024-02133
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 31, 2024
    Report Date
    September 10, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D11: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735821R, LOT/SERIAL/VERSION #: P901037 H3) THE MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. HARDWARE PARTS WERE REPLACED. THE CAMERA WAS RETURNED TO THE MANUFACTURE FOR ANALYSIS. THE RETURNED POWER SUPPLY UNIT (PSU) HAD NICKS AND SCRATCHES ON THE HOUSING AND LENSES. A CHECK OF THE EVENT LOG SHOWED INTERMITTENT FIRMWARE INCOMPATIBILITY DATING BACK TO FEB 2019. THERE WAS A BATTERY VOLTAGE LOW MESSAGE ALONG WITH BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED. THE PSU FAILED AN ACCURACY TEST (AAK) AT .841MM WITH A PASSING THRESHOLD OF .250MM. THIS PSU HAD NOT BEEN PREVIOUSLY RETURNED FOR A FAILURE. 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: 9 735821, SERIAL/LOT #: UNKNOWN, UBD: UNKNOWN, UDI#:UNKNOWN H3) A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE 9735821 CAMERA/NAVIGATION SYSTEM. IT WAS REPORTED THAT THE SYSTEM UNDERWENT A COMPREHENSIVE EVALUATION, AND IT WAS CONFIRMED THAT THE BUMP SENSOR ON THE CAMERA HAD BEEN TRIGGERED AND THE CAMERA LOCALIZER WAS FAULTED. THE ISSUE WAS RESOLVED BY REPLACING THE CAMERA. AFTER CAMERA REPLACEMENT, THE SYSTEM PERFORMED AS INTENDED. THE FOLLOWING CODES APPLY B01, C08, AND D02. 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 ABOUT A NAVIGATION SYSTEM ISSUE IDENTIFIED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM DI SPLAYED "LOCALIZER FAULTED" FOR THE CAMERA. THEY TRIED A REBOOT WITH NO CHANGE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1894637 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

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