BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION FLEXENT

    MDR report key: 11563542 · Received March 24, 2021

    Report

    Report Number
    1723170-2021-00783
    Event Type
    Malfunction
    Date Received
    March 24, 2021
    Date of Event
    February 10, 2021
    Report Date
    May 27, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    PGW
    PMA / PMN Number
    K200723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: A SOFTWARE ANALYSIS WAS INITIATED. HOWEVER, THE SOFTWARE EVALUATION FOUND THAT A PROBABLE CAUSE WAS UNABLE TO BE DETERMINED. 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

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. THE UNIQUE IDENTIFIER WAS NOT KNOWN AT THE TIME OF REPORTING. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9736217, SERIAL/LOT #: (B)(4). THE MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. B01, C13, D02 . THE SYSTEM WAS RETURNED TO THE MANUFACTURE FOR EVALUATION. AFTER FUNCTIONAL TESTING AND VISUAL/PHYSICAL EXAMINATION THE REPORTED ISSUE WAS CONFIRMED. THE SYSTEM WAS TESTED AND UPON BOOT UP DISPLAYED ERROR BOOT TEXT "INVALID ARCH-INDEPENDENT ELF MAGIC." AND THEN "PRESS ANY KEY TO CONTINUE". WHEN KEY WAS PRESSED IT WOULD CONTINUE THIS CYCLE WITHOUT RESOLUTION. SSD WAS SWAPPED WITH A KNOW GOOD UNIT. THEN THE SYSTEM WOULD BOOT PROPERLY AND TOUCH FUNCTION WERE NORMAL. SSD FROM UNIT ON A KNOWN GOOD SYSTEM WOULD DISPLAY SAME SYMPTOMS, BOOT TEXT STATING AN ERROR. B01, C13, D02 THE MANUFACTURE DATE WAS NOT KNOWN AT THE TIME OF REPORTING. 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 DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT UPON INSTALLATION OF THE SYSTEM, IT WOULD NOT BOOT UP. THE FIRST BOOT UP, WAS ABLE TO GET ONTO THE LOGIN SCREEN, BUT THE TOUCH-SCREEN WAS BEING CONSISTENTLY RESPONSIVE. IT WAS NOTED THAT THE SYSTEM WAS POWERED DOWN CORRECTLY THROUGH THE SOFTWARE. THE MANUFACTURING REPRESENTATIVE (REP) SWAPPED TO ANOTHER OUTLET AND THEN UPON BOOT UP, THE SYSTEM DISPLAYED, "INVALID ARC INDEPENDENT ELF MAGIC, FAILED TO BOOT" PRESS ANY KEY TO CONTINUE, THEN TO GRUB MENU. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE OCCURRED. TECHNICAL SERVICES (TS) WALKED THE REP THROUGH BOOTING INTO RECOVERY MODE, BUT THE SYSTEM WOULD CONTINUALLY LOOP BACK TO THE BOOT UP ERROR. IT WAS LATER NOTED THAT AFTER THE TOUCH SCREEN WAS INTERMITTENTLY UNRESPONSIVE UPON FIRST BOOT UP, THE SYSTEM WAS SHUT DOWN CORRECTLY THROUGH SOFTWARE. IT WAS NOTED THAT THE MOST LIKELY CAUSE WAS EITHER THE BIOS OR BOOT SECTOR OF THE HARD DRIVE OR THE OS HAD BEEN CORRUPTED. IT WAS NOTED THAT THE CAUSE WAS MOST LIKELY FAULTY HARDWARE WHICH WAS UNPREVENTABLE. IT WAS REPORTED THAT THE CAUSE OF THE ISSUE IS EITHER THE BIOS OR BOOT SECTOR OF THE HARD DRIVE OR THE OS HAS BECOME CORRUPT. MOST LIKELY FAULTY HARDWARE, UNPREVENTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461395 STEALTHSTATION FLEXENT EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT PGW MEDTRONIC NAVIGATION, INC 9736242

    Patients

    Seq Age Sex Outcome Treatment
    1