BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7

    MDR report key: 10341395 · Received July 29, 2020

    Report

    Report Number
    1723170-2020-02051
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Date of Event
    July 28, 2020
    Report Date
    September 16, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450968
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H2) ADDITIONAL INFORMATION: SEE B5. 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) ONSITE FUNCTIONAL AND VISUAL EXAMINATION WAS PERFORMED BY A MANUFACTURER REPRESENTATIVE. TROUBLESHOOTING WAS PERFORMED TO DETERMINED THE CAUSE OF THE EVENT. THE CAUSE OF THE EVENT WAS FOUND TO BE AN ISSUE WITH THE GRAPHICS CARD. 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

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE REPORTED ISSUE OCCURRED DURING A CRANIOTOMY. IT WAS REPORTED THAT THE ISSUE OCCURRED WHEN NAVIGATION WAS NOT IN USE AND THAT A HARD RESTART OF THE NAVIGATION SYSTEM, RELOADING OF PATIENT DATA AND REGISTRATION RESTORED FUNCTIONALITY TO THE SYSTEM. ADDITIONALLY, IT WAS NOTED THAT THE IMAGE ON THE MONITOR WAS DISTORTED PRIOR TO BEING "FROZEN."

    Additional Manufacturer Narrative · 1

    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. THERE WAS NO PATIENT INVOLVEMENT. THE SITE REPORTED THE A "SQUARE LIKE BROKEN IMAGE" WAS DISPLAYED ON THE NAVIGATION SYSTEM AND THEN THE SYSTEM SHUT DOWN. THE SYSTEM RESTARTED TO THE BLUE SCREEN (LIKE BEFORE THE CRANIAL APPLICATION) AND FROZE AGAIN. AFTER A MANUAL SYSTEM RESTART, THE ISSUE RESOLVED. ADDITIONAL INFORMATION RECEIVED THE NEXT DAY INDICATED AN ISSUE OCCURRED (IT WAS UNKNOWN IF IT OCCURRED DURING A PROCEDURE AS NO FURTHER INFORMATION WAS PROVIDED). UPLOADING THE PATIENT DATA AND REGISTRATION OF THE PATIENT WAS SUCCESSFUL. HOWEVER, AFTER APPROXIMATELY 30 MINUTES, THE 3D IMAGE "BROKE DOWN." NAVIGATION WORKED NORMALLY AFTER A COUPLE OF MINUTES, BUT THEN THE 3D IMAGE BROKE DOWN AGAIN ON THE SYSTEM MONITOR AND THE SYSTEM THEN FROZE. THE PROBABLE CAUSE WAS EXPECTED TO BE LOW POWERING SYSTEM FAILURE, UNINTERRUPTIBLE POWER SUPPLY (UPS) FAILURE, OR BATTERY FAILURE. A SYSTEM CHECKOUT WAS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803434 STEALTHSTATION S7 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733858 00613994450968

    Patients

    Seq Age Sex Outcome Treatment
    1