BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 22004313 · Received May 12, 2025

    Report

    Report Number
    1723170-2025-01932
    Event Type
    Malfunction
    Date Received
    May 12, 2025
    Date of Event
    May 7, 2025
    Report Date
    July 8, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    UDI-DI
    00763000272807
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME ; PRODUCT ID: 9735821, PRODUCT TYPE: 2543-MNAV - SYSTEM H3: ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. H6: MULTIPLE FDD/ANNEX A CODES WERE REPORTED. A1102 WAS CODED FOR THE ERROR MESSAGE. A05 WAS CODED FOR THE ORANGE LIGHT-EMITTING DIODE (LED) CAMERA ISSUE. 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

    D9, H2, H3: THE RETURN OF 9735821 PROVIDED THE LOT NUMBER P903146. THE HARDWARE WAS RETURNED AND ANALYSIS WAS PERFORMED. THE RETURNED POSITIONING SENSOR UNIT (PSU) CONTAINED SCRATCHES ON THE HOUSING AND LENSES. A CHECK OF THE EVENT LOG REVEALED INTERMITTENT FIRMWARE INCOMPATIBILITY DATING BACK TO OCTOBER 2021 AND INTERMITTENT ILLUMINATOR CURRENT LOW, DATING BACK TO DECEMBER 2020. 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 .444MM WITH A PASSING THRESHOLD OF .250MM. 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 SYSTEM GAVE A LOCALIZER FAULTED ERROR AND THE ORANGE LIGHT-EMITTING DIODE (LED) WAS ON. THE ERROR WOULD GO OFF BY REBOOTING THE SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482681 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735667 00763000272807

    Patients

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