BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 20146443 · Received September 5, 2024

    Report

    Report Number
    1723170-2024-02532
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    August 14, 2024
    Report Date
    November 20, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H2: ADDITIONAL INFORMATION ADDED TO B5. SEE RR# 1723170-2024-03274 FOR THE INSTRUMENT 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

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: PRODUCT ID 9733457 (LOT: 221128) H3,H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. 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

    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 ISSUE WAS NOT WITH THE SOFTWARE, BUT THE INSTRUMENT.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT ACCURACY WAS NOT ACHIEVED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE WAS A VERIFY FAILURE ON THE INSTRUMENT SCREEN. THIS WAS DESCRIBED AS INACCURATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2140838 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11...