BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 22090740 · Received May 27, 2025

    Report

    Report Number
    1723170-2025-02089
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    May 19, 2025
    Report Date
    May 27, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00763000272739
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: PRODUCT ID: 9735821 (LOT NUMBER: P903261). H3, H6) THE SYSTEM WAS SERVICED IN THE FIELD. IN SUMMARY, THE OPTICAL CAMERA WAS REPLACED TO RESOLVE. CODES B01, C08, AND D02 ARE APPLICABLE. H3, H6) THE CAMERA, PRODUCT ID: 9735821 (LOT NUMBER: P903261), WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. IN SUMMARY, THE COMPLAINT WAS CONFIRMED. THE RETURNED POSITIONING SENSOR UNIT (PSU) HAD SCRATCHES ON THE HOUSING AND LENSES. A CHECK OF THE EVENT LOG SHOWED INTERMITTENT FIRMWARE INCOMPATIBILITY DATING BACK TO (B)(6) 2020 AND INTERMITTENT ILLUMINATOR CURRENT LOW DATING BACK TO (B)(6) 2021. THERE WAS A BATTERY VOLTAGE LOW MESSAGE ALONG WITH BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED. THE PSU FAILED AN ACCURACY TEST (AAK) AT .296 MILLIMETERS (MM) WITH A PASSING THRESHOLD OF .250MM. CODES B01, C02, C07, C08, C13, AND 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 USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM DISPLAYED 'LOCALIZER FAULTED' UPON BOOT UP. STATUS MESSAGES INDICATED FAULTS SUCH AS BUMP DETECTED, INTERNAL TEMPERATURE EXCEEDED, BATTERY VOLTAGE LOW, AND STORAGE TEMPERATURE EXCEEDED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329798 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00763000272739

    Patients

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