BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 19921041 · Received August 6, 2024

    Report

    Report Number
    1723170-2024-02008
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    May 14, 2024
    Report Date
    August 16, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00763000359881
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3/H6: THE CAMERA, LOT NUMBER: P921888, WAS RETURNED FOR ANALYSIS. A CHECK OF THE EVENT LOG SHOWED THAT THE STORAGE TEMPERATURE HAD BEEN EXCEEDED. OTHERWISE, THE POSITIONING SENSOR UNIT (PSU) PASSED AN ACCURACY TEST (AAK). THE TEMPERATURE SENSOR WAS CLEARED AND THE PSU IS NOW FULLY FUNCTIONAL. CODES B01, C02, AND D02 APPLY. 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

    D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735820, LOT NUMBER: T905116; PRODUCT ID: 9735821, LOT NUMBER: UNKNOWN G2: FOREIGN COUNTRY - SPAIN H3/H6: THE SYSTEM WAS SERVICED IN THE FIELD AND HARDWARE WAS REPLACED. CODES B01, C07, AND D02 APPLY. THE POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) WAS RETURNED AND ANALYZED. A CHECK OF THE EVENT LOG DISPLAYED A FIRMWARE MISSING OR CORRUPTED MESSAGE. DURING FUNCTIONAL TESTING, THE SCU WAS NOT ABLE TO TRACK INSTRUMENTS. CODES B01, C02, AND D02 APPLY. 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

    2024-MAY-14; 00800215 (REP, FOR): MEDTRONIC RECEIVED INFORMATION REGARDING AN NAVIGATION SYSTEM AND AUTOMATED TRAJECTORY GUIDANCE UNIT BEING USED IN A BIOPSY PROCEDURE. IT WAS REPORTED THAT THE SYSTEM PRESENTED AN ORANGE ALERT ON THE CAMERA. NEVERTHELESS, THE SYSTEM WORKED AS INTENDED. THE SURGERY WAS SUCCESSFULLY PERFORMED WITH NO PATIENT IMPACT. WHILE CHECKING THE CAMERA SETTING BY LOGGING INTO THE ADMIN USER, THE CAMERA SHOWED AN SYSTEM CONTROL UNIT (SCU) CONNECTION FAILURE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647413 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00763000359881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11