BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 22172348 · Received June 9, 2025

    Report

    Report Number
    1723170-2025-02254
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    May 29, 2025
    Report Date
    October 23, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    UDI-DI
    00763000272739
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H2) CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735821R, LOT #: P906022:- H2) PLEASE SEE SECTION D9 FOR WHEN THE DEVICE WAS AVAILABLE FOR EVALUATION. H3, H6) THE POSITIONING SENSOR UNIT (PSU), LOT NUMBER: P906022, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PSU WAS FOUND TO HAVE SCRATCHES ON THE HOUSING AND LENSES. A CHECK OF THE EVENT LOG SHOWED MANY INSTANCES OF INTERMITTENT FIRMWARE INCOMPATIBILITY, AND ALSO INTERMITTENT ILLUMINATOR CURRENT. CODES B01, C02, AND 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.

    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: 9735762 (SOFTWARE VERSION: 2.1.0) AND PRODUCT ID: 9735821R (SERIAL/LOT: UNKNOWN). H3, H6) THE SYSTEM WAS SERVICED IN THE FIELD. IN SUMMARY, HARDWARE PARTS WERE REPLACED. CODES B01, C20, AND D15 ARE APPLICABLE. H6) MULTIPLE ANNEX A CODES WERE APPLIED TO CAPTURE THIS EVENT. A0908 CAPTURES THE REGISTRATION ACCURACY AT ROUGHLY 6.5MM WHILE A0709 CAPTURES THE TRACKING ISSUES EXPERIENCED. 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

    H3, H6: A SOFTWARE ANALYSIS WAS INITIATED. HOWEVER, THE SOFTWARE EVALUATION FOUND THAT A PROBABLE CAUSE WAS UNABLE TO BE DETERMINED. CODES B01, C19, D15 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 DURING AN ELECTRODE AND PROBE PLACEMENT PROCEDURE. IT WAS REPORTED THAT THE CAMERA EXPERIENCED INTERMITTENT ISSUES TRACKING THE INSTRUMENT AND REFERENCE FRAME AFTER REPLACING THE SOLID-STATE DRIVE (SSD) AND RE-INSTALLING SOFTWARE. THE REFERENCE FRAME WAS INITIALLY NOT DETECTED BY THE CAMERA, BUT AFTER LOGGING OUT AND BACK IN, THE FRAME BECAME VISIBLE. DURING REGISTRATION, THE INSTRUMENT INTERMITTENTLY TRACKED AND FLICKERED, RESULTING IN A SUBOPTIMAL REGISTRATION ACCURACY OF APPROXIMATELY 6.5 MILLIMETERS (MM). MULTIPLE LOG OUTS AND SWAPPING OF PROBES AND SPHERES WERE REQUIRED TO ACHIEVE SUCCESSFUL REGISTRATION WITH ACCURACY OF LESS THAN 2 MM. ADDITIONAL OBSERVATIONS INCLUDED THE CAMERA NOT DISPLAYING THE REFERENCE FRAME WHEN POINTED DIRECTLY AT IT, THE APPLICATION DETECTING THE FRAME ONLY WHEN THE CAMERA WAS NOT DIRECTLY POINTED AT THE REFERENCE FRAME, AND THE APPLICATION NOT RECOGNIZING THE REFERENCE FRAME EVEN WHEN ONE SPHERE WAS COVERED AT A TIME. THE APPLICATION RECOGNIZED A NEW REFERENCE FRAME AFTER THE ORIGINAL WAS REPLACED AND LOGGING OUT AND BACK IN. TROUBLESHOOTING STEPS INCLUDED RECORDING THE SOFTWARE BEHAVIOR, SWAPPING FRAMES, SPHERES, AND INSTRUMENTS, LOGGING OUT AND BACK IN, VISUAL INSPECTION OF PARTS PRIOR TO INSTALLATION, SYSTEM SELF-TEST, AND LOG REVIEW. IT WAS NOTED THAT THE SPHERES BEING USED WERE MEDTRONIC SPHERES. THE TRACKING INFORMATION FOR BOTH FRAMES USED WAS ABOUT .085 AND THE HIGHEST AN ANGLE WAS ABLE TO GET WAS ABOUT .12. THE PROBES WERE BOTH ABOUT .2 AND AT AN INTENSE ANGLE, THEY COULD GET TO ABOUT A .3. NO ENVIRONMENTAL FACTORS WERE IDENTIFIED AS CONTRIBUTING TO THE EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355785 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665 00763000272739

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female SEE H11...