BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 NAVIGATION

    MDR report key: 10960310 · Received December 7, 2020

    Report

    Report Number
    1723170-2020-03188
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    December 2, 2020
    Report Date
    January 29, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H2: ADDITIONAL INFORMATION: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 9733449, LOT #: 180627, PRODUCT ID: 9733449, LOT #: 18042771 PRODUCT ID: 9733447, LOT #: 19481. 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

    SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 9733597, LOT #: 130917. PRODUCT ID: 9733449, LOT #: UNKNOWN. PRODUCT ID: UNK_NAV_COMP, LOT #: UNKNOWN H3: ANALYSIS OF THE AXIEM CABLE REVEALED THAT THE CABLE JACKET HAD SEPARATED AT THE LEMO CONNECTOR EXPOSING THE SHIELD WIRE, BUT NO CONDUCTORS. A CONTINUITY TEST ALSO REVEALED AN OPEN AT PIN 1 OF THE USB CABLE. FDM B01, FDR C02, FDC D02 H3: A MEDTRONIC REPRESENTATIVE VISITED THE SITE TO PERFORM A SYSTEM CHECKOUT. THEY CONCLUDED THAT TWO OF THE STRAIGHT SUCTIONS ONLY VERIFIED WHEN HELD IN DIVOT AT STEEP ANGLE. THE 45 DEGREE SUCTION HAD THE SAME ISSUE AND WAS LIKELY BENT. THE SYSTEM PERFORMED AS INTENDED BUT THERE WERE DAMAGED INSTRUMENTS. 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

    CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: CABLE 9733597 EXTERNAL AXIEM PWR/DATA, LOT/SERIAL: UNKNOWN. 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. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT WHILE SETTING UP THE SYSTEM, THE AXIEM BOX WAS NOT ABLE TO CONNECT TO THE SYSTEM. THROUGH MULTIPLE REBOOTS THE BOX SHOWED AN 8 ON THE DISPLAY AND SHOWED IT AS DISCONNECTED IN THE SOFTWARE. THE AXIEM CABLE WAS RESEATED WITH NO RESOLUTION. DURING TROUBLESHOOTING, A SECOND AXIEM BOX AND EMITTER WERE UTILIZED AND THE SAME SYMPTOMS WERE OCCURRING. THE USB VIEW WAS OPENED AND IT WAS FOUND THAT THE AXIEM IS NOT BEING SEEN BY THE SYSTEM. THE USB CABLE WAS RESEATED INTO ANOTHER PORT WITH NO RESOLUTION. THE COMMUNICATION PORTION OF THE CABLE IS FRAYED AND HAS SOME ELECTRICAL TAPE ON IT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1424752 STEALTHSTATION S7 NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 "SEE H10...."