BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 20688995 · Received November 14, 2024

    Report

    Report Number
    1723170-2024-03569
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    January 29, 2024
    Report Date
    October 21, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    UDI-DI
    00763000360498
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735825R, SERIAL/LOT #: (B)(6), UDI#: (B)(4) ; PRODUCT ID: 9735777, SERIAL/LOT #: (B)(6), PRODUCT ID: 9735780, SERIAL/LOT #: UNKNOWN, PRODUCT ID: 9735521ENT, SERIAL/LOT #: (B)(6), PRODUCT ID: 9735824, SERIAL/LOT #: (B)(6), H3: THE SYSTEM WAS SERVICED IN THE FIELD, AND THE ELECTROMAGNETIC INTERFACE, THE ELECTROMAGNETIC CONTROLLER, THE FLAT EMITTER, THE E LECTROMAGNETIC POWER CABLE, THE UNIVERSAL SERIAL BUS (USB) 2.0 ELECTROMAGNETIC CABLE, AND THE SIDE MOUNT EMITTER WERE REPLACED. CODES B01, C02, D02 ARE APPLICABLE TO THIS ANALYSIS. D9, H2, H3: THE HARDWARE (9735824, LOT #1600674019) WAS RETURNED AND ANALYSIS WAS PERFORMED. THE CONTROLLER WAS FOUND TO BE DEFECTIVE. ALL CONNECTED COMPONENTS DISPLAYED RED STATUS ON LAT STATION AND WOULD NOT COMMUNICATE. CIRCUIT BOARD FLASHED ZEROS AND TWOS THAT APPEAR TO BE ERROR CODE 002. CODES B01, C02, D02 ARE APPLICABLE TO THIS ANALYSIS. THE HARDWARE (9735825R, LOT #1600504320) WAS RETURNED AND ANALYSIS WAS PERFORMED. THE EM INTERFACE WAS TESTED AND DID FAULT IMMEDIATELY WHEN PLUGGED INTO THE LAT STATION. NONE OF THE LEDS WERE FUNCTIONAL AND THE INTERFACE WOULDN'T CONNECT TO EMTEST. CODES B01, C02, D02 ARE APPLICABLE TO THIS ANALYSIS. THE HARDWARE (9735777, LOT #211228) WAS RETURNED AND ANALYSIS WAS PERFORMED. THE RETURNED CABLE HAD NO PHYSICAL DAMAGE AND PASSED A CONTINUITY TEST WITH NO OPENS OR SHORTS DETECTED. CODES B01, C19, D14 ARE APPLICABLE TO THIS ANALYSIS. THE HARDWARE (9735780) WAS RETURNED AND ANALYSIS WAS PERFORMED. THE RETURNED CABLE HAD NO PHYSICAL DAMAGE AND PASSED A CONTINUITY TEST WITH NO OPENS OR SHORTS DETECTED. CODES B01, C19, D14 ARE APPLICABLE TO THIS ANALYSIS. THE HARDWARE (9735521ENT, LOT #603006103) WAS RETURNED AND ANALYSIS WAS PERFORMED. THE SIDE EMITTER WAS TESTED ON THE ANALYST'S LAT STATION FOR AN OVERNIGHT BURN-IN TEST AND DISPLAYED ALL GREEN STATUS FOR THE DURATION OF THE TEST. THE EMITTER WAS FULLY FUNCTIONAL. CODES B01, C19, D14 ARE APPLICABLE TO THIS ANALYSIS. H6: MULTIPLE ANNEX G CODES WERE REPORTED. G04035 CORRESPONDS TO CONCOMITANT PRODUCT 9735824 THAT COMPRISES THE REPORTED EVENT. G02018 CORRESPONDS TO CONCOMITANT PRODUCTS 9735825R AND 9735521ENT THAT COMPRISES THE REPORTED EVENT. G02004 CORRESPONDS TO CONCOMITANT PRODUCTS 9735777 AND 9735780 THAT COMPRISES THE REPORTED 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9733752, LOT/SERIAL #: (B)(6). 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: 9733752R, LOT/SERIAL #: (B)(6) H3) THE EMITTER WAS RETURNED FOR ANALYSIS. THERE WAS NO ISSUES WITH THE RETURNED FLAT EMITTER. THE FLAT EMITTER WAS CONNECTED TO OUR LAT STATION AND PASSED AN OVERNIGHT BURN-IN TEST WITHOUT ISSUES. 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, SERIAL/LOT #: (B)(4), D9, H2, H3: THE HARDWARE (9735824, LOT # 603003383) WAS RETURNED AND ANALYSIS WAS PERFORMED. THE CONTROLLER WAS FOUND TO BE DEFECTIVE. ALL CONNECTED COMPONENTS DISPLAYED RED STATUS ON LAT STATION AND WOULD NOT COMMUNICATE. CIRCUIT BOARD FLASHED ZEROS AND TWOS THAT APPEAR TO BE ERROR CODE 002. CODES FDM B01, FDR C02, FDC D02 ARE 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE BREAKOUT BOX HAD NO LIGHTS, AND IT WAS NOT POSSIBLE TO HEAR THE EMITTER. DURING TROUBLESHOOTING, THE ELECTROMAGNETIC NAVIGATION INTERFACE UNIT WAS CONNECTED IN SELF-TEST. THE CONTROLLER BOX WAS DISCONNECTED AND RECONNECTED. IT WAS INDICATED THAT THE CONTROLLER FAULTED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205135 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735669 00763000360498

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown