BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S8 SYSTEM

    MDR report key: 10601754 · Received September 29, 2020

    Report

    Report Number
    1723170-2020-02564
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Date of Event
    September 24, 2020
    Report Date
    January 13, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169838918
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT ARCHIVE WAS REVIEWED FOR SOFTWARE ANALYSIS. THE SOFTWARE EVALUATION DETERMINED THERE WAS NOT ENOUGH EVIDENCE TO ESTABLISH THE ROOT CAUSE OF THE REPORTED ISSUE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735736, SERIAL/LOT: N/A, VERSION: (B)(4). A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO PERFORM A SYSTEM CHECK OUT ,AND THEY FOUND THE SYSTEM FUNCTIONED AS INTENDED. NO PROBLEMS WERE DETECTED. FDM10, FDR213, FDC67 ARE APPLICABLE TO THE SYSTEM CHECKOUT. ARCHIVES WERE RETURNED FOR SOFTWARE ANALYSIS. ANALYSIS IS IN PROGRESS. FDM4118, FDR3233, FDC11 ARE APPLICABLE TO THE SOFTWARE ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY. IT WAS REPORTED THAT THE SURGEON FELT INACCURATE EVERYWHERE. THE SURGEON TOUCHED THE PATIENT'S TURBINATE, AND THE SYSTEM WOULD SHOW THEM ON THE SEPTUM, SO THERE WAS ABOUT A 3-5 MM LATERAL INACCURACY. THE SURGEON TRIED TO RE-REGISTER, AND THE MANUFACTURER REPRESENTATIVE TRIED DIFFERENT TECHNIQUES, BUT THEY WERE UNSUCCESSFUL ON GETTING A MORE ACCURATE REGISTRATION. THE SURGEON CONTINUED WITH THE CASE. THERE WAS A FIVE MINUTE DELAY AND NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066812 STEALTHSTATION S8 SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735669 00643169838918

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR