BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 21834882 · Received April 14, 2025

    Report

    Report Number
    1723170-2025-01657
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    April 1, 2025
    Report Date
    April 14, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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: 9735821R, SERIAL/LOT #: (B)(6), UBD: UNKNOWN, UDI#: (B)(4) 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: P902951. IT WAS REPORTED THAT THE RETURNED POSITIONING SENSOR UNIT (PSU) HAD 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 .785MM WITH A PASSING THRESHOLD OF .250MM. CODES B01, C08 AND D02 ARE ALSO APPLICABLE TO THIS ANALYSIS. A05: APPLICABLE TO LOCALIZER FAULTED A1102: APPLICABLE TO THE "LOCALIZER FAULTED" ERROR MESSAGE A110201: APPLICABLE TO THE ISSUE OCCURRING DURING BOOT UP 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 DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT A LOCALIZER FAULTED MESSAGE APPEARED ON BOOT UP. THE SITE USED ANOTHER CAMERA TO PROCEED WITH THE CASE. THIS RESULTED IN A 30-MINUTE DELAY IN THE PROCEDURE. IT WAS LATER CONFIRMED THAT THERE WAS AN INTERNAL BATTERY ISSUE WITH THE CAMERA. IT WAS UNKNOWN IF THERE WAS PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007190 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665

    Patients

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