BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S8 SYSTEM

    MDR report key: 11167044 · Received January 13, 2021

    Report

    Report Number
    1723170-2021-00118
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    January 5, 2021
    Report Date
    February 22, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE SYSTEM CONTROL UNIT WAS RETURNED TO MEDTRONIC FOR ANALYSIS. TESTING WAS CONDUCTED AND THE BATTERY VOLTAGE WAS CONFIRMED TO BE LOW. FDM B01, FDR C02, AND FDC D02 ARE APPLICABLE TO THE SYSTEM CONTROL UNIT ANALYSIS. THE CAMERA WAS NOT REPLACED. LOT NUMBER OF CAMERA: P9-00420 LOT NUMBER OF SYSTEM CONTROL UNIT: T9-00327 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 · 0

    H3, H6: THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. THE SYSTEM CONTROL UNIT WAS SENT TO THE VENDOR FOR ANALYSIS. VENDOR ANALYSIS FOUND THAT THE FAILURE WAS CONFIRMED AND ISOLATED TO MAINBOARD BATTERY FAULT. MAINBOARD BATTERY WAS REPLACED FOLLOWED BY PRODUCT TESTING. 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

    A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. IT WAS REPORTED THAT THE CAMERA SYSTEM CONTROL UNIT (SCU) WAS REPLACED. THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: CAMERA 9735821 VEGA BASE S8 SVC SYSTEM CONTROL 9735820 SCU VEGA S8 SVC. 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 OUTSIDE OF A PROCEDURE WITH NO PATIENT PRESENT. IT WAS STATED FROM A MANUFACTURER REPRESENTATIVE (REP) THAT DURING A VISIT TO THE SITE AND TRYING TO CONNECT THE CAMERA TO THE NAVIGATION SYSTEM IT WAS NOTED THAT THEY WERE GETTING A GREEN LINE OF COMMUNICATION TO THE CAMERA CART BUT THERE WAS A RED LIGHT NOTED ON THE CAMERA. THE SYSTEM WAS REBOOTED AND INTERCONNECT CABLE WAS RE SEEDED. THE SYSTEM WAS NOTED TO BE WORKING 10 MIN BEFORE AS THE SYSTEM WAS USED IN A CASE. TECHNICAL SERVICES (TS) HAD THE REP CHECK THE NDI TOOL BOX ON THE NAVIGATION SYSTEM THROUGH ADMIN AND IT WAS NOTED THAT THE REP WAS UNABLE TO SEE THE CAMERA AT ALL. THE REP POWERED DOWN THE SYSTEM AND REMOVED THE PLUG FROM THE WALL FOR 3 MIN. UPON POWERING BACK ON THE SYSTEM THE REP WAS ABLE TO HEAR TWO BEEPS BUT THE SYSTEM STILL SHOWED A RED FAULT LIGHT. ADDITIONAL INFORMATION WAS RECEIVED: THE REP THEN REPORTED THAT ANOTHER REP WAS USING THIS SYSTEM FOR A DEMO. THE REP STATED THAT THE SYSTEM "SHORTED OUT" AND THE LOCALIZER WAS NOT CONNECTED. THIS WAS RESOLVED AFTER A REBOOT. ADDITIONAL INFORMATION WAS RECEIVED: ANOTHER MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO REPLACE THE CAMERA AND THE SYSTEM BOOTED UP NORMALLY WITH NO FAULT LIGHT ON THE CAMERA OR LOCALIZER DISCONNECTED MESSAGE. THE REP TRIED TO DO A MOCK REGISTRATION AND COUL DN'T TRACK THE FRAME OR TWO DIFFERENT PROBES. THE REP HAD DIFFERENT SPHERES ON ALL OF THESE AND CONFIRMED THE CAMERA LASER WAS AIMED TOWARDS THE TRACKING AREA. THE REP OPENED UP THE "NDI TOOLBOX" AND FOUND THE SYSTEM CONTROL UNIT (SCU) HARDWARE FAULT STATING "SCU BATTERY FAULT". THE REP RESEATED THE CONNECTIONS IN THE SCU AND IT DID NOT RESOLVE THE ISSUE. THE REP TRIED THE NEW CAMERA AND IT ALSO WOULD NOT TRACK. THE REP TRIED ANOTHER CAMERA CART AND THE SAME BEHAVIOR OCCURRED. THE REP DID NOT TRY A SEPARATE MAIN CART BECAUSE THE LIKELY ISSUE IS THAT THE SCU IS FAILING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61428 STEALTHSTATION S8 SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1