BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® S7

    MDR report key: 9842627 · Received March 17, 2020

    Report

    Report Number
    1723170-2020-00930
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    March 13, 2020
    Report Date
    March 25, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H2/H3/H6: THE COMPUTER THAT WAS REPLACED WAS CHECKED OUT BY A MEDTRONIC REPRESENTATIVE AND NO FAILURE WAS FOUND. THE COMPUTER IS STILL IN USE. CODES 10, 213 AND 67 ARE APPLICABLE TO THIS TROUBLESHOOTING. H2: ADDITIONAL INFORMATION WAS RECEIVED. B5 WAS UPDATED AND THE LOT NUMBER OF THE COMPUTER IS 1854040. 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

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR (LOWER/MID SPINE) PROCEDURE. DURING THE PROCEDURE, THREE IMAGE ACQUISITIONS WERE TAKEN. THE FIRST AND SECOND WERE RECEIVED ON THE NAVIGATION SYSTEM, HOWEVER, THE THIRD IMAGE WAS TRANSFERRED, BUT THE NAVIGATION SYSTEM WAS SAID TO BE IN A STATE OF WAITING AND THE TRANSFER FAILED. THE IMAGE WAS ABLE TO TRANSFER FROM THE IMAGING SYSTEM TO THE MOBILE VIEWING STATION (MVS). THE IMAGING AND NAVIGATION SYSTEMS WERE REBOOTED. THE THIRD IMAGE ACQUISITION WAS THEN ATTEMPTED TO BE MANUALLY PUSHED TO THE NAVIGATION SYSTEM, BUT THE ISSUE PERSISTED. THE PROCEDURE WAS THEN COMPLETED WITHOUT THE USE OF NAVIGATION OR IMAGING. DURING INSPECTION AFTER THE PROCEDURE, THE ISSUE WAS REPRODUCED ONCE EVERY FOUR ATTEMPTS TO TRANSFER IMAGES TO THE NAVIGATION SYSTEM. THE LOCAL AREA NETWORK (LAN) CABLE WAS REPLACED, BUT THE ISSUE PERSISTED. THE REPORTED ISSUE DID NOT RESULT IN A PROCEDURE DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. THE ROLLING STONE COMPUTER WAS A BACKUP ONE WHICH BELONGS TO MEDTRONIC JAPAN.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735225, SERIAL/LOT #: UNKNOWN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE ISSUE WAS CONFIRMED AND THE SYSTEM COMPUTER WAS REPLACED. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. 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 FOR A SACROILIAC AND THORACOLUMBAR (LOWER/MID SPINE) PROCEDURE. DURING THE PROCEDURE, THREE IMAGE ACQUISITIONS WERE TAKEN. THE FIRST AND SECOND WERE RECEIVED ON THE NAVIGATION SYSTEM, HOWEVER, THE THIRD IMAGE WAS TRANSFERRED, BUT THE NAVIGATION SYSTEM WAS SAID TO BE IN A STATE OF WAITING AND THE TRANSFER FAILED. THE IMAGE WAS ABLE TO TRANSFER FROM THE IMAGING SYSTEM TO THE MOBILE VIEWING STATION (MVS). THE IMAGING AND NAVIGATION SYSTEMS WERE REBOOTED. THE THIRD IMAGE ACQUISITION WAS THEN ATTEMPTED TO BE MANUALLY PUSHED TO THE NAVIGATION SYSTEM, BUT THE ISSUE PERSISTED. THE PROCEDURE WAS THEN COMPLETED WITHOUT THE USE OF NAVIGATION OR IMAGING. DURING INSPECTION AFTER THE PROCEDURE, THE ISSUE WAS REPRODUCED ONCE EVERY FOUR ATTEMPTS TO TRANSFER IMAGES TO THE NAVIGATION SYSTEM. THE LOCAL AREA NETWORK (LAN) CABLE WAS REPLACED, BUT THE ISSUE PERSISTED. THE REPORTED ISSUE DID NOT RESULT IN A PROCEDURE DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308442 STEALTHSTATION® S7 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9734056

    Patients

    Seq Age Sex Outcome Treatment
    1