BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 21560478 · Received March 10, 2025

    Report

    Report Number
    1723170-2025-01227
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 28, 2025
    Report Date
    March 10, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00763000359881
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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, H3, H6: MULTIPLE FDD/ANNEX A CODES WERE REPORTED. A05 WAS CODED FOR COMBINED POSITION SENSOR UNIT/SYSTEM CONTROL UNIT (PSU/SCU) FIRMWARE INDICATED UNKNOWN FIRMWARE AND THE OPTICAL LOCALIZER (PSU) INDICATED UNKNOWN FIRMWARE. A1102 WAS CODED FOR SYSTEM INDICATED LOCALIZER FAULTED. THE SYSTEM WAS SERVICED IN THE FIELD BY A MEDTRONIC REPRESENTATIVE. NO FAILURES WERE FOUND. CODES B01, C19, AND D14 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 INDICATED LOCALIZER FAULTED. WHEN ENTERING SELF TEST, THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT UNDER INTERNAL COMPONENT FIRMWARE, THE COMBINED POSITION SENSOR UNIT/SYSTEM CONTROL UNIT (PSU/SCU) FIRMWARE INDICATED UNKNOWN FIRMWARE AND THE OPTICAL LOCALIZER (PSU) INDICATED UNKNOWN FIRMWARE. AFTER GOING BACK TO THE SYSTEM, THE ERRORS WERE NO LONGER PRESENT AND THE SYSTEM APPEARED TO BE FUNCTIONING AS INTENDED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156677 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00763000359881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown