BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 19250483 · Received May 6, 2024

    Report

    Report Number
    1723170-2024-01202
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    April 29, 2024
    Report Date
    June 7, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00763000359881
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3/H6 - EVALUATION OF THE RETURNED EM CONTROLLER 9735824R LOT# 1600809319 AND CABLE 9735777 LOT# 210921 FOUND NO FAULT WITH THE RETU RNED COMPONENTS. CODES B01, C19, D14 APPLY. 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: 9735824; PRODUCT ID: 9735777, H6: MULTIPLE FDD/ANNEX A CODES WERE REPORTED. A0709 WAS CODED FOR NOT BEING ABLE TO TRACK THE TWO PATIENT TRACKERS. A0902 WAS CODED FOR PORTS 3 AND 4 ON INSTRUMENT INTERFACE HAVING ORANGE LEDS AND THE EMITTER NOT CHIRPING. H6: MULTIPLE ANNEX G CODES WERE REPORTED. G04018 CORRESPONDS TO POWER CABLE CONCOMITANT PRODUCT THAT COMPRISES THE REPORTED EVENT. G04035 CORRESPONDS TO EM CONTROLLER CONCOMITANT PRODUCT THAT COMPRISES THE REPORTED EVENT. H3, H6: A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE MANUFACTURER REPRESENTATIVE REP LACED THE EM CONTROLLER AND POWER CABLE. THE NAVIGATION SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. B01, C02, C13, 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 DURING PLANNED MAINTENANCE. IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE WAS CHECKING THE ELECTROMAGNETIC (EM) EQUIPMENT AND COULD NOT TRACK TWO PATIENT TRACKERS. THE MANUFACTURER REPRESENTATIVE NOTED THAT PORTS 3 AND 4 ON THE INSTRUMENT INTERFACE HAD ORANGE LEDS NEXT TO THEM BUT THERE WERE NO FAULT MESSAGES IN THE SOFTWARE. BOTH THE EMITTER AND INSTRUMENT INTERFACE DISPLAYED AS CONNECTED. THE MANUFACTURER REPRESENTATIVE PLUGGED IN ANOTHER KNOWN WORKING EMITTER AND INSTRUMENT INTERFACE TO THE NAVIGATION SYSTEM AND THE ISSUE PERSISTED. ON THE KNOWN WORKING NAVIGATION SYSTEM, BOTH SETS OF EMITTERS AND INSTRUMENT INTERFACES FUNCTIONED AS INTENDED AND WERE ABLE TO TRACK BOTH PATIENT TRACKERS THE MANUFACTURER REPRESENTATIVE OPENED FOR TESTING. TECHNICAL SERVICES (TS) HAD THE MANUFACTURER REPRESENTATIVE RECONNECT THE EMITTER AND INSTRUMENT INTERFACE BOX TO THE SYSTEM AND RUN THE EM DIAGNOSTICS. NOTHING ABNORMAL WAS SEEN IN THE DIAGNOSTICS, BUT THE MANUFACTURER REPRESENTATIVE AGAIN CONFIRMED THAT THE EMITTER WAS NOT CHIRPING AND THE PATIENT TRACKER COULD NOT BE TRACKED. THE INSTRUMENT INTERFACE ALSO HAD AMBER LEDS ON PORTS 3 AND 4. TS HAD THE MANUFACTURER REPRESENTATIVE CHECK THE LEDS ON THE UNINTERRUPTIBLE POWER SUPPLY (UPS) AND THEY DISPLAYED AS EXPECTED AND NO OTHER POWER ISSUES WERE SEEN ON THE SYSTEM. REBOOTING THE SYSTEM ALSO HAD NO EFFECT ON THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768029 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00763000359881

    Patients

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