BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S8 SYSTEM

    MDR report key: 10934883 · Received December 2, 2020

    Report

    Report Number
    1723170-2020-03142
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 24, 2020
    Report Date
    January 11, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00763000272739
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3) ANALYSIS ON THE RETURNED CONTROLLER AND CABLE FOUND NO FAILURE FOUND. ANALYSIS DETERMINED THAT THE CONTROLLER WAS ABLE TO COMMUNICATE AND TRACK TOOLS AS EXPECTED. THE CABLES HAS NO OPENS OR SHORTS. CONTINUATION OF D10) PRODUCT ID: 9735777, LOT #: 603002684; PRODUCT ID: 9735824, LOT #: 190930. 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

    ADDITIONAL INFORMATION WAS RECEIVED. THE CONTROLLER WAS RECEIVED OR ANALYSIS; HOWEVER, ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. (B)(4). ADDITIONAL INFORMATION WAS RECEIVED - THE LOT/SERIAL NUMBERS WERE PROVIDED. PRODUCT ID: 9735825, SN: (B)(4); PRODUCT ID: 9735777, LOT #: M704430B344. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS SERVICED IN THE FIELD AND FAILED HARDWARE TESTS DUE TO AXIEM COMMUNICATION. THE DOCTOR WAS UNABLE TO CONNECT AXIEM BEFORE A CASE. THE EM CONTROLLER AND CABLE WERE REPLACED TO RESOLVE THE ISSUE. (B)(4). OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735824, LOT #: UNKNOWN. PRODUCT ID: 9735777, LOT #: UNKNOW. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT NO PATIENT WAS PRESENT. THIS HAPPENED WHILE SETTING UP FOR A CASE BEFORE THE PATIENT WAS IN THE ROOM.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE LOCALIZER WAS INITIALIZING. THE ELECTROMAGNETIC (EM) EQUIPMENT WAS UNABLE TO GET PAST INITIALIZING DURING A CASE. THE SITE REBOOTED BUT THERE WAS NO CHANGE OTHER THAN THE LIGHTS ON THE INTERFACE BOX DID NOT TURN ON THIS TIME. THE SITE GOT THEIR INTERFACE BOX FROM A DIFFERENT SYSTEM AND ENCOUNTERED THE SAME ISSUES SO THEY SWITCHED TO A NEW SYSTEM AND MOVED ON. IT WAS REPORTED THAT NO PATIENT WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399893 STEALTHSTATION S8 SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00763000272739

    Patients

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