BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® S7¿

    MDR report key: 20128632 · Received September 3, 2024

    Report

    Report Number
    1723170-2024-02480
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    August 23, 2024
    Report Date
    October 1, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    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 735672, ; PRODUCT ID: 9735225R, H3, H6: THE SYSTEM WAS SERVICED IN THE FIELD BY A MEDTRONIC REPRESENTATIVE. THE COMPLEMENTARY METAL-OXIDE SEMICONDUCTOR (CMOS) BATTERY AND COMPUTER WERE REPLACED. CODES B01, C02, AND D02 ARE APPLICABLE. FOR THE BATTERY, G02002 IS APPLICABLE. FOR THE COMPUTER, G02007 IS 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

    H3, H6) THE PRODUCT ID: 9735225, LOT NUMBER: 1895761, RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE REPORTED ISSUE WAS CONFIRMED. THE COMPUTER HAD A FAILING / DEAD COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS) BATTERY. 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 THE SYSTEM WAS BOOTING TO NO SIGNAL. DURING TROUBLESHOOTING, THE COMPLEMENTARY METAL-OXIDE SEMICONDUCTOR (CMOS) BATTERY WAS RESET AND THE ISSUE DID NOT RESOLVE. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE (REP) COULD NOT HEAR THE FANS RUNNING AND THEY WERE UNABLE TO OPEN COMPACT DISK (CD) DRIVE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712138 STEALTHSTATION® S7¿ NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown