BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 NAVIGATION

    MDR report key: 11224197 · Received January 25, 2021

    Report

    Report Number
    1723170-2021-00204
    Event Type
    Malfunction
    Date Received
    January 25, 2021
    Date of Event
    January 22, 2021
    Report Date
    February 12, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 9733597, LOT #: 161228 H3: A MEDTRONIC REPRESENTATIVE VISITED THE SITE TO PERFORM A SYSTEM CHECKOUT. IT WAS REVEALED THAT THE SYSTEM PERFORMED AS INTENDED AFTER THE AXIEM CABLE WAS REPLACED. FDM B01, FDR C19, FDC D14 H3: ANALYSIS OF THE AXIEM CABLE REVEALED THAT THE CABLE JACKET SEPARATED AT THE LEMO CONNECTOR. A CONTINUITY TEST HAD ALSO SHOWN OPENS FOR THE SHIELD AND PIN 1 OF THE USB CABLE. THE COMPLAINT WAS CONFIRMED. FDM B01, FDR C02, FDC D15 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

    2021-JAN-25 E1 (REP): ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE CAUSE OF THE CABLE DAMAGE WAS UNKNOWN.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9660651, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A HEALTHCARE PROFESSIONAL REGARDING A NAVIGATION SYSTEM DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE AXIEM BOX WAS NOT CONNECTED TO THE SYSTEM. NONE OF THE PORTS WERE ACTIVE AND THE DISPLAY ON THE BACK OF THE BOX READ "8". TROUBLESHOOTING WAS DONE PRIOR TO THE CALL AND THE SYSTEM WAS REBOOTED, THE AXIEM WAS REBOOTED, AND THE BOX WAS PHYSICALLY DISCONNECTED AND RECONNECTED TO THE SYSTEM. WHILE ON THE CALL THE SYSTEM WAS REBOOTED IN TO THE ENT SOFTWARE WHERE IT WAS ABLE TO CONNECT AND THE EM INTERFACE SHOWED NO FAULTS. THEN THEY SWITCHED BACK TO CRANIAL AND CONTINUED TO BE CONNECTED. THERE WAS A DELAY OF ABOUT 45 MINUTES. THE ISSUE WAS SAID TO BE RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT FURTHER TROUBLESHOOTING WAS DONE ON THE SITE. THE AXIEM WASN'T COMMUNICATING WHEN THEY FIRST LAUNCHED THE CRANIAL SOFTWARE. THE YEXITED THE SOFTWARE AND WENT INTO THE ENT SOFTWARE. AT FIRST THEY WERE GETTING AN 8 ON THE BOX AND THE EMITTER WAS NOT CHIRPING. AFTER SITTING FOR 3-5 MINUTES COMMUNICATION WAS RESTORED IN THE SOFTWARE. THEY THEN WENT BACK INTO THE CRANIAL SOFTWARE AND THE SYSTEM WAS FUNCTIONING. IT WAS STATED THAT THERE LOOKED TO BE SOME DAMAGE ON THE AXIEM COMMUNICATION CABLE. THE CABLE WAS BENT BY THE LEMO CONNECTOR THAT PLUGGED INTO THE AXIEM BOX. WHEN THEY MANIPULATED THE CABLE AT THAT SPOT COMMUNICATION WAS THEN LOST AGAIN. THEY WERE REQUESTING ANOTHER CABLE FOR EOGS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120510 STEALTHSTATION S7 NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856

    Patients

    Seq Age Sex Outcome Treatment
    1 19 MO