BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 21385050 · Received February 14, 2025

    Report

    Report Number
    1723170-2025-00707
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Date of Event
    January 17, 2023
    Report Date
    February 14, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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: 9 73580; PRODUCT ID: 9735825R, SERIAL/LOT #: (B)(6) AND UDI#: (B)(4). H3: A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT HARDWARE PARTS WERE REPLACED. THE NAVIGATION SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. HARDWARE ANALYSIS WAS COMPLETED ON THE RETURNED FOOTSWITCH AND IT WAS FOUND TO BE NONFUNCTIONAL WHEN CONNECTED TO A KNOWN GOOD SYSTEM. THERE WAS NO APPARENT PHYSICAL DAMAGE. ANALYSIS WAS COMPLETED ON THE RETURNED EM INTERFACE AND IT HAD ISSUES WITH PORTS 5 AND 6. AFTER WARMUP, BOTH HAD SOLID AMBER LIGHTS AND WERE UNABLE TO RECOGNIZE TOOLS. THE CABLE ALSO HAD DAMAGE. H6: B01, C02 AND D02 APPLY TO THE EM INTERFACE CONCOMITANT PRODUCT ID: 9735825R. B01, C19 AND D15 APPLY TO THE SYSTEM CHECKOUT. B01, C07 AND D02 APPLY TO THE FOOTSWITCH CONCOMITANT PRODUCT ID: 973580 THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW THROUGH CAPA 624392. 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 WHILE THE MEDTRONIC REPRESENTATIVE (REP) WAS ON SITE COMPLETING A TRAINING, THEY WERE UNABLE TO USE THE BREAKOUT BOX AND FOOT SWITCH. THE SITE SWAPPED THE BREAKOUT BOX FROM ANOTHER SYSTEM AND THE NEW ONE WORKED. THE REP TESTED THE FOOTSWITCH AND WAS ABLE TO REPLICATE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460286 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown