BEUDAMED
    FDA Adverse Event Death Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 23255479 · Received October 9, 2025

    Report

    Report Number
    1723170-2025-03414
    Event Type
    Death
    Date Received
    October 9, 2025
    Date of Event
    September 13, 2023
    Report Date
    January 13, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H2: ADDITIONAL INFORMATION ADDED TO B5. 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: 9735736, VERSION: 2.0.1. H6: NO PRODUCTS HAVE BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 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.

    Additional Manufacturer Narrative · 0

    H2-3) THE SOFTWARE ANALYSIS CONCLUDED THAT THERE WAS INSUFFICIENT INFORMATION TO DETERMINE IF A SOFTWARE ANOMALY CAUSED THE REPORTED EVENT. THE CASE WAS REVIEWED. AS PER INFO PROVIDED ON THE DATE 20-OCT-2025, THE ISSUE WAS DUE TO THE REFERENCE FRAME MOVED. SUSPECTED THE USER ERROR MIGHT HAVE CAUSED THE REPORTED BEHAVIOR. CODES: B01, C19, D15. 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

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT REFERENCE FRAME (NOT TRACKER) WAS MOVED. THEY NOTICED IT, BUT THEY CONTINUED WITHOUT NAVIGATION. IT WAS CONFIRMED THAT THE SURGERY DID CONTINUE AND WAS NOT ABORTED. THE HEMORRHAGE WAS SEEN DURING NAVIGATION AS THE BIOPSY NEEDLE BROKE THE VEIN IN THE BRAIN. THE SYSTEM WAS USED AND INACCURACY WAS DETECTED LATER. THE SURGEON ENDED UP AT AN INCORRECT LOCATION.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT DURING THE BIOPSY, THE TARGETED AREA MOVED DURING NAVIGATION AND THE BIOPSY FAILED. THE PATIENT PASSED AWAY A FEW DAYS AFTER THE BIOPSY DUE TO A LARGE CEREBRAL HEMORRHAGE. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF MORE THAN 1 HOUR DUE TO THIS ISSUE BEFORE THE USE OF NAVIGATION AND ULTIMATELY THE SURGERY WAS ABORTED. THE PATIENT REFERENCE FRAME HAD MOVED, AND THE SURGEON MADE THE DECISION TO CONTINUE WITHOUT NAVIGATION. THE AMOUNT OF INACCURACY WAS UNKNOWN. THE INACCURACY WAS NOT RELATED TO THE NAVIGATION SYSTEM. THE NAVIGATION TRACKER MANUALLY MOVED, AND THE SURGEON TOOK THE RISK TO CONTINUE WITHOUT NAVIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2512872 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9735665

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Death "SEE H11...."