BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 21800168 · Received April 8, 2025

    Report

    Report Number
    1723170-2025-01597
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    March 31, 2025
    Report Date
    May 7, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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: 9 735821, H6: MULTIPLE FDD/ANNEX A CODES WERE REPORTED. A05 WAS CODED FOR "LOCALIZER FAULTED", NDI TOOLBOX HAD BUMP AND TEMPERATURE EXCEEDED. A1102 WAS CODED FOR SYSTEM WAS DISPLAYING "LOCALIZER FAULTED". NO PRODUCTS HAVE BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    WORK ORDER COMPLETED: H3, H6) A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. IT WAS REPORTED THAT THE CAMERA WAS REPLACED TO RESOLVE THE ISSUE. CODES B01, C08 AND D02 ARE APPLICABLE. H3, H6: ANALYSIS WAS PERFORMED FOR PRODUCT: 9735821R, LOT NUMBER: P903485. IT WAS REPORTED THAT THE RETURNED POSITIONING SENSOR UNIT (PSU) CONTAINED SCRATCHES ON THE HOUSING LENSES. A CHECK OF THE EVENT LOG SHOWED INTERMITTENT FIRMWARE INCOMPATIBILITY AND INTERMITTENT ILLUMINATOR CURRENT LOW. THERE WAS ALSO A BATTERY VOLTAGE LOW MESSAGE ALONG WITH BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED MESSAGES. THE PSU FAILED AN ACCURACY TEST (AAK) AT .603MM WITH A PASSING THRESHOLD OF .250MM. THIS PSU HAS NOT BEEN RETURNED PREVIOUSLY. CODES B01, C08 AND D02 ARE ALSO 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 THE SYSTEM WAS DISPLAYING "LOCALIZER FAULTED". DURING TROUBLESHOOTING, THE MANUFACTURER REPRESENTATIVE (REP) NOTES THE NETWORK DEVICE INTERFACE (NDI) TOOLBOX HAD BUMP AND TEMPERATURE EXCEEDED. IT WAS NOTED THAT THE PROBABLE CAUSE OF THE ISSUE WAS THECOMPLEMENTARY METAL-OXIDE SEMICONDUCTOR (CMOS) BATTERY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707556 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665

    Patients

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