BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 24365482 · Received February 17, 2026

    Report

    Report Number
    1723170-2026-00253
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Date of Event
    January 26, 2026
    Report Date
    April 30, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H2-3) THE SOFTWARE INVESTIGATION CONCLUDED THAT THERE WAS INSUFFICIENT INFORMATION TO DETERMINE WHETHER A SOFTWARE ANOMALY CONTRIBUTED TO THE REPORTED BEHAVIOR. THE LOGS WERE REVIEWED FROM THE INCIDENT DATE WHICH HAD A SINGLE SESSION, WITH NO REBOOTS, X SERVER CRASHES, KERNEL FAULTS, OR OPERATING SYSTEM (OS) HANGS DURING THE INCIDENT PERIOD. THE SYSTEM REMAINED RESPONSIVE THROUGHOUT THE SESSION. AT 11:25:31, THE UNIVERSAL SERIAL BUS (USB) 2.0 HUB AND SECONDARY WEIDA HI-TECH MILDEX270 TOUCHSCREEN CONTROLLER DISCONNECTED AND RE-ENUMERATED AFTER ~43 SECONDS, A PATTERN CONSISTENT WITH A PHYSICAL CONNECTION DISTURBANCE. QMLGUISERVICE LOGS SHOWED MULTIPLE EXPIRED TOUCH POINT WARNINGS AND A BRIEF BURST OF QML BINDING LOOP WARNINGS IMMEDIATELY FOLLOWING THE RECONNECTION, ALONG WITH REPEATED CLEARED LOW-PERFORMANCE GUI WARNINGS, INDICATING SUSTAINED PHANTOM OR UNSTABLE TOUCH INPUT. A SINGLE TRANSIENT NVIDIA EDID READ WARNING WAS OBSERVED WITH NO ASSOCIATED GRAPHICS PROCESSING UNIT (GPU), X SERVER, OR APPLICATION FAILURES. ALL STEALTHAPPLICATION SERVICES SHUT DOWN NORMALLY. BASED ON THE TIMING OF EVENTS AND OBSERVED LOG SIGNATURES, IT WAS SUSPECTED THAT PHYSICAL DISPLACEMENT OF THE MONITOR BEZEL MAY HAVE APPLIED PRESSURE TO THE CAPACITIVE TOUCHSCREEN, POTENTIALLY GENERATING PHANTOM TOUCH INPUT EVENTS AND CAUSING THE GUI TO APPEAR UNRESPONSIVE. DURING THIS PERIOD, THE UNDERLYING SYSTEM SOFTWARE, GPU, AND APPLICATION SERVICES CONTINUED TO OPERATE NORMALLY. NORMAL SYSTEM BEHAVIOR WAS OBSERVED AFTER THE BEZEL WAS RESEATED. CODES: B01, C19, AND D15 H2) PLEASE SEE SECTION D9 FOR WHEN THE SOFTWARE WAS AVAILABLE FOR EVALUATION. 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 735737, VERSION#: 2.1.0, H3, H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. 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 THERE WAS SOME SOFTWARE FREEZING OCCURRING ON THE SYSTEM. THE SITE STATED THAT THE BEZEL ON THE MONITOR HOUSING WAS POPPED OUT. IT WAS UNCLEAR WHETHER THE FREEZING WAS DUE TO THE BEZEL PUTTING PRESSURE ON THE TOUCH SCREEN OR IF THE SOFTWARE ACTUALLY FROZE. THE MANUFACTURER REPRESENTATIVE (REP) WILL MONITOR THE SITUATION BUT THE SYSTEM WAS NOW BEING USED CLINICALLY IN A CASE WITH NO FREEZING. THE BEZEL WAS POPPED BACK IN TO PROPER CONFIGURATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430915 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665

    Patients

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