BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 21462799 · Received February 25, 2025

    Report

    Report Number
    1723170-2025-00981
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    February 17, 2025
    Report Date
    March 19, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WORK ORDER COMPLETE: H3, H6) A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. IT WAS REPORTED THAT THE CAMERA WAS REPLACED. THE SYSTEM THEN PERFORMED AS INTENDED. CODES B01, C08 AND D02 ARE APPLICABLE. H3: ANALYSIS WAS PERFORMED FOR PRODUCT: 9735821, LOT NUMBER: P900771. IT WAS REPORTED THAT THE RETURNED POSITIONING SENSOR UNIT (PSU) HAD MANY NICKS AND SCRATCHES ON THE HOUSING AND LENSES. A CHECK OF THE EVENT LOG SHOWED INTERMITTENT FIRMWARE INCOMPATIBILITY, AND INTERMITTENT ILLUMINATOR CURRENT LOW. THERE WAS A BATTERY VOLTAGE LOW MESSAGE ALONG WITH BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED. THE PSU FAILED AN ACCURACY TEST (AAK) AT .620MM WITH A PASSING THRESHOLD OF .250MM. CODES B01, C08 AND D02 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 735821, H6: MULTIPLE FDD/ANNEX A CODES WERE REPORTED. A1102 WAS CODED FOR THE LOCALIZER FAULTED MESSAGE. A05 WAS CODED FOR LOCALIZER FAULTED, BUMP DETECTED BATTERY FAULT, BUMP DETECTED, AND STORAGE TEMPERATURE EXCEEDED. 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DURING A PLANNED MAINTENANCE (PM), THE MANUFACTURER REPRESENTATIVE (REP) FOUND A LOCALIZER FAULTED MESSAGE IN AN OPTICAL PROCEDURE OF THE SOFTWARE. DURING TROUBLESHOOTING, THE MANUFACTURER REPRESENTATIVE (REP) OPENED THE NETWORK DEVICE INTERFACE (NDI) TOOLBOX AND FOUND THE FOLLOWING MESSAGES: BUMP DETECTED BATTERY FAULT, BUMP DETECTED, AND STORAGE TEMPERATURE EXCEEDED. IT WAS NOTED THAT THE PROBABLE CAUSE OF THE ISSUE WAS THE POSITION SENSOR UNIT (PSU) INTERNAL BATTERY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698315 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11