BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 13237410 · Received January 12, 2022

    Report

    Report Number
    1723170-2022-00049
    Event Type
    Malfunction
    Date Received
    January 12, 2022
    Date of Event
    December 21, 2021
    Report Date
    February 3, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE CAMERA WAS REPLACED. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735821R, SERIAL/LOT #: UNKNOWN, IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    H2) ADDITIONAL INFORMATION: THE SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS UNRELATED TO A SOFTWARE ISSUE. THE ISSUE WAS FOUND WITH THE CAMERA. THE SOFTWARE FUNCTIONED AS DESIGNED. THE LOT NUMBER FOR THE CAMERA HAS BEEN UPDATED TO P900352. H3: THE RETURNED CAMERA WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND THAT THE LEFT LENS OF THE POSITIONING SENSOR UNIT (PSU) WAS SCRATCHED. A CHECK OF THE EVENT LOG SHOWED INTERMITTENT ENTRIES FOR FIRMWARE INCOMPATIBILITY DATING BACK TO MARCH OF 2019. THERE WERE ALSO INTERMITTENT ENTRIES FOR LOW ILLUMINATOR CURRENT DATING BACK TO NOVEMBER OF 2020. ADDITIONALLY, THE PSU FAILED AN ACCURACY TEST (AAK) AT .56 MM WITH A PASSING THRESHOLD OF .25 MM. THIS PSU HAS BEEN RETURNED ONCE PREVIOUSLY FOR A FAILED AAK TEST AND WAS REPAIRED AND RETURNED TO SERVICE INVENTORY. ANALYSIS FOUND THAT THE REPORTED EVENT WAS RELATED TO A ELECTRICAL ISSUE. H6: FDM B01, FDR C02, AND FDC D02 ARE APPLICABLE TO THE HARDWARE ANALYSIS. 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.

    Description of Event or Problem · 0

    ON (B)(6) 2021 00728254 (HCP): MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHEN TRYING TO VERIFY THE SITE'S INSTRUMENTS, THE CAMERA WOULD NOT RECOGNIZE THE INSTRUMENTS, THIS WAS CONFIRMED TO BE HAPPENING ON ALL THE INSTRUMENTS THE SITE WAS REGISTERING. THE SITE TRIED REBOOTING THE SYSTEM TWICE WITH NO RESOLVE. ONLY WHEN TURNING THE CAMERA TO THE RIGHT WAS THE SITE ABLE TO INTERMITTENTLY TRACK. THE SITE TRIED WIPING DOWN THE CAMERA LENSES WITH NO RESOLVE. THE SITE DECIDED TO ABANDON THE USE OF NAVIGATION. THERE WAS A DELAY LESS THAN ONE HOUR. THE MANUFACTURER REPRESENTATIVE (REP) WAS ABLE TO REPLICATE THE SYSTEM ONLY TRACKING INSTRUMENTS ON THE RIGHT AND NOT THE LEFT. THE REP CHECKED THE NDI TOOLBOX AND THERE WAS NO FAULTS, ERRORS OR WARNINGS. TECHNICAL SERVICES (TS) HAD THE REP CHECK THE CAMERA WAS CLEAN AND THE GEOMETRY ERROR OF INSTRUMENTS WAS ALSO WITHIN LIMITS. EVERYTHING ON THE SYSTEM CHECKED FINE BESIDES ONLY BEING ABLE TO TRACK ON THE RIGHT NOT LEFT. THERE IS CONFLICTING INFORMATION IF THERE WAS SERIOUS INJURY WITH PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED. IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT AND A NON MEDTRONIC PRODUCT WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102145 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female "SEE H10...."