BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION¿ ENT NAVIGATION SYSTEM

    MDR report key: 8207399 · Received January 1, 2019

    Report

    Report Number
    1723170-2019-06515
    Event Type
    Malfunction
    Date Received
    January 1, 2019
    Date of Event
    December 10, 2018
    Report Date
    January 22, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994380005
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE LOGS FOR THE NAVIGATION SYSTEM WERE REVIEWED BY MEDTRONIC PERSONNEL. HOWEVER, THE LOGS PROVIDED NO ADDITIONAL INSIGHT INTO THE PROBABLE CAUSE OF THE ANOMALY. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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 THAT THE SITE WAS ABLE TO LOAD A NEW PATIENT DISC TO RESOLVE THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED/SUBMITTED TO THE MANUFACTURER FOR AN EVALUATION TO BE CONDUCTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE NAVIGATION SYSTEM DISPLAYED THERE WAS NO IMAGE DATA WHEN ATTEMPTING TO LOAD A PATIENT THROUGH THE UNSTRUCTURED ALTERNATE MODULE OPTION. IT WAS NOTED THAT WHEN LOADING, THE NAVIGATION SYSTEM TOOK AN EXTENDED AMOUNT OF TIME TO LOAD AND THE PATIENT SELECTION POP-UP DID NOT APPEAR. THE REPRESENTATIVE THEN ATTEMPTED TO LOAD THE IMAGE THROUGH STANDARD DIGITAL INTERCOMMUNICATION OF MEDICINE (DICOM) WHERE THE SYSTEM PROMPTED THE USER WITH THE PATIENT SELECTION BUT THE NAVIGATION SYSTEM DISPLAYED AN "UNABLE TO INTERPRET HEADER DATA" MESSAGE INDICATING THE IMAGE WAS COMPRESSED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183 FUSION¿ ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733560XOM 00613994380005

    Patients

    Seq Age Sex Outcome Treatment
    1