BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 22057392 · Received May 20, 2025

    Report

    Report Number
    1723170-2025-02029
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    May 7, 2025
    Report Date
    June 11, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS WAS PERFORMED FOR PRODUCT: 9735943, LOT NUMBER: UNKNOWN. IT WAS REPORTED THAT THE RETURNED CABLE HAD A FEW SMALL CUTS IN THE CABLE JACKET BUT NO CONDUCTORS HAVE BEEN EXPOSED. OTHERWISE, THE CABLE PASSED A CONTINUITY TEST WITH NO OPENS OR SHORTS DETECTED. ALREADY REPORTED CODES B01, C02 AND D02 ARE APPLICABLE TO THIS ANALYSIS. H3: ANALYSIS WAS PERFORMED FOR PRODUCT: 9735784, LOT NUMBER: 190304. IT WAS REPORTED THAT THE CABLE WAS RETURNED WITH BOTH FUSES REMOVED. BOTH FUSES HAD BLOWN. OTHERWISE, THE CABLE PASSED A CONTINUITY TEST WITH NO OPENS OR SHORTS DETECTED. ALREADY REPORTED CODES B01, C02 AND D02 ARE ALSO APPLICABLE TO THIS ANALYSIS. H3: ANALYSIS WAS PERFORMED FOR PRODUCT: 9735773, LOT NUMBER: 1924. IT WAS REPORTED THAT THE BATTERY WAS TESTED (49.83 V) WITH A KNOWN GOOD UPS FOR A 24HR PERIOD AND TESTED WITH NO ISSUES. UPS WAS THEN UNPLUGGED FROM AC POWER AND CONTINUED TO RUN UNDER BATTERY POWER FOR THE SET 11.5 MINUTES BEFORE THE UPS SHUT DOWN AS PROGRAMED. THERE WAS NO FAULT FOUND. CODES B01, C19 AND D14 ARE APPLICABLE TO THIS ANALYSIS. H3: ANALYSIS WAS PERFORMED FOR PRODUCT: 9735787, LOT NUMBER: 19230212. IT WAS REPORTED THAT THE UNINTERRUPTIBLE POWER SUPPLY (UPS) WAS TESTED WITH A KNOWN GOOD BATTERY FOR A 24HR PERIOD AND TESTED WITH NO ISSUES. UPS WAS THEN UNPLUGGED FROM AC POWER AND CONTINUED TO RUN UNDER BATTERY POWER FOR THE SET 11.5 MINUTES BEFORE THE UPS SHUT DOWN AS PROGRAMMED. THERE WAS NO FAULT FOUND. CODES B01, C19 AND D14 ARE ALSO APPLICABLE 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

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9 735773; PRODUCT ID: 9735787, PRODUCT ID: 9735943, PRODUCT ID: 9735784, WORK ORDER COMPLETED: H3, H6) A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. IT WAS REPORTED THAT THE BATTERY, UNINTERRUPTIBLE POWER SUPPLY (UPS), POWER CORD, AND UPS POWER CABLE WERE REPLACED. THE SYSTEM THEN PERFORMED AS INTENDED. CODES B01, C02 AND D02 ARE APPLICABLE. A0719: APPLICABLE TO THE SYSTEM BEING OFF WHEN THE SITE RETURNED. (B)(6): APPLICABLE TO THE SYSTEM BEING UNRESPONSIVE AND WOULD NOT BOOT. A13: APPLICABLE TO ISSUE OCCURRING WHEN DOWNLOADING THE IMAGE. 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 WHILE PLUGGED INTO A RED OUTLET, THE SITE WENT TO UPLOAD AN IMAGE OVER PACS AND LEFT THE SYSTEM TO DOWNLOAD THE IMAGE. WHEN THEY RETURNED, THE SYSTEM WAS OFF. IT WAS UNRESPONSIVE AND WOULD NOT BOOT, WITH NO LIGHTS OR FAN NOISE PRESENT. THE SITE MOVED THE SYSTEM TO SEVERAL OTHER OUTLETS, AND THE SYSTEM STILL WOULD NOT BOOT. IT WAS NOTED TO BE COMPLETELY UNRESPONSIVE. TROUBLESHOOTING WAS ATTEMPTED BY OPENING THE FRONT AND BACK PANELS, AND THE BATTERY WAS NOTED TO HAVE SOME DARK RINGS ON THE BOTTOM. THE MANUFACTURER REPRESENTATIVE (REP) TRIED STARTING UP THE SYSTEM WITHOUT THE BATTERY TO NO SUCCESS. THE REP CALLED AT A LATER TIME TO REPORT THAT AFTER REPLACING THE EXTERNAL POWER CABLE, UNINTERRUPTED POWER SOURCE (UPS), AND BATTERY, THERE WERE STILL NO LIGHTS ON THE UPS. IT WAS SUSPECTED THAT THE BACKORDERED INTERNAL AC POWER CABLE WAS NEEDED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72812 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11