BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 7758687 · Received August 7, 2018

    Report

    Report Number
    1723170-2018-03864
    Event Type
    Malfunction
    Date Received
    August 7, 2018
    Date of Event
    October 15, 2017
    Report Date
    August 7, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00643169504394
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: FOKKENS W. BACHERT C. BERNAL-SPREKELSEN M. ET AL. RHINOLOGY FUTURE DEBATES, AN EUFOREA REPORT. (2017). RHINOLOGY 55: 298-304, 2017. HTTPS://DOI.ORG/10.4193/RHINO17.221. THE EXACT SYSTEM INFORMATION COULD NOT BE DETERMINED AS IT WAS NOT PROVIDED. HOWEVER, THE SYSTEM LISTED ON THIS FORM WAS AT THE ADDRESS LISTED IN THE ARTICLE DURING THE TIME SOME OF THE SURGERIES WERE COMPLETED. DEVICE UDI NOT PROVIDED AS ACTUAL PRODUCT USED FOR THIS STUDY IS UNKNOWN. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. NO FURTHER INFORMATION PROVIDED IN THE JOURNAL ARTICLE OR FROM THE AUTHORS. THE AUTHOR COULD NOT PROVIDE ANY ADDITIONAL INFORMATION OR INSIGHT AS HE WAS NOT AT THE SITE WHEN THE SURGERIES WERE PERFORMED. NO REQUEST FOR SERVICE HAVE BEEN RECEIVED FROM THE CUSTOMER REGARDING THESE EVENTS. NO PARTS HAVE BEEN REPLACED OR RETURNED TO THE MANUFACTURER FOR EVALUATION. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S SURGICAL NAVIGATION SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. DEVICE NOT RETURNED BY CUSTOMER.

    Description of Event or Problem · 1

    THE ATTACHED JOURNAL ARTICLE WAS FORWARDED BY MEDTRONIC REPRESENTATIVE. ARTICLE INDICATED THE USE OF SURGICAL NAVIGATION SYSTEM. THE FIRST RHINOLOGY FUTURE DEBATES WAS HELD IN BRUSSELS IN DECEMBER 2016, ORGANIZED BY EUFOREA (EUROPEAN FORUM FOR RESEARCH AND EDUCATION IN ALLERGY AND AIRWAYS DISEASES). THE PURPOSE OF THESE DEBATES IS TO BRING NOVEL DEVELOPMENTS IN THE FIELD OF RHINOLOGY TO THE ATTENTION OF THE MEDICAL, PARAMEDICAL AND PATIENT COMMUNITY, IN A HIGHLY CREDIBLE AND BALANCED CONTEXT. FOR THE FIRST TIME IN RHINOLOGY, A PEER TO PEER SCIENTIFIC EXCHANGE WITH KEY EXPERTS IN THE FIELD OF RHINOLOGY AND KEY MEDICAL COLLEAGUES FROM LEADING INDUSTRIES LET TO A BRAINSTORMING AND DISCUSSION EVENT ON A NUMBER OF HOT ISSUES IN RHINOLOGY. NOVEL DEVELOPMENTS ARE PRESENTED BY KEY EXPERTS FROM INDUSTRY AND/OR KEY THOUGHT LEADERS IN RHINOLOGY, AND THEN FOLLOWED BY A LIVELY DEBATE ON THE POTENTIAL POSITIONING OF NEW DEVELOPMENTS IN CARE PATHWAYS, THE STRENGTHS AND WEAKNESSES OF THE NOVEL DEVELOPMENT(S), AND COMPARISONS WITH EXISTING AND/OR COMPETING PRODUCTS, DEVICES, AND/OR MOLECULES. PANELLISTS EXPRESSED THEIR FRUSTRATION THAT SYSTEMS VERY OFTEN SEEM TO BECOME LESS PRECISE DURING THE PROCEDURE, ESPECIALLY IN MORE PROLONGED CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596814 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION 00643169504394

    Patients

    Seq Age Sex Outcome Treatment
    1