BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 21657083 · Received March 20, 2025

    Report

    Report Number
    1723170-2025-01402
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Date of Event
    March 14, 2025
    Report Date
    April 18, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00763000272739
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6) THE CABLE, PRODUCT ID: 9735842, LOT: 191021, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. IN SUMMARY, NO FAULTS WERE FOUND. IT HAD NO PHYSICAL DAMAGE AND PASSED A CONTINUITY TEST WITH NO OPENS OR SHORTS DETECTED. PREVIOUSLY REPORTED CODE, B01, IS APPLICABLE AS WELL AS NEWLY REPORTED CODES, C19 AND D14. 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 735842, H6: THE SYSTEM WAS SERVICED IN THE FIELD BY A MEDTRONIC REPRESENTATIVE. HARDWARE WAS REPLACED. THE NAVIGATION SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. CODES B01, C02, D02 ARE APPLICABLE. 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 A CAMERA CART MONITOR WAS COMPLETELY BLACK. THE MANUFACTURER REPRESENTATIVE (REP) CHECKED THAT THE CAMERA WAS STILL RECEIVING POWER. THE REP CHECKED SELF TEST AND BOTH THE SYSTEMS' BATTERIES SHOWED 100% AND CONNECTIONS WERE FINE. DURING TROUBLESHOOTING, THE REP SWAPPED THE MAIN CART MONITOR POWER CABLE INTO THE CAMERA CART MONITOR POWER INPUT. THE CAMERA CART MONITOR TURNED ON AND FUNCTIONED NORMALLY. THE REP CHECKED SELF TEST. THE CAMERA CART MONITOR WAS SEEN IN SELF TEST AS CONNECTED. THIS LIKELY MEANT THE CAMERA CART UNINTERRUPTIBLE POWER SUPPLY (UPS) WAS STILL GOOD. IT WAS NOTED THAT THE PROBABLE CAUSE OF THE ISSUE WAS THE CAMERA CART MONITOR POWER CABLE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332103 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00763000272739

    Patients

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