BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 6144105 · Received December 4, 2016

    Report

    Report Number
    1723170-2016-05623
    Event Type
    Injury
    Date Received
    December 4, 2016
    Date of Event
    November 7, 2016
    Report Date
    December 4, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994380005
    PMA / PMN Number
    K001284
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SITE CHARGE RN, (B)(6) DECLINED TO PROVIDE PATIENT IDENTIFIER . ON (B)(6) 2016 A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THERE WAS NO ALLEGATION OF A MEDTRONIC DEVICE MALFUNCTION, HOWEVER, IT APPEARED THE SURGEON'S USE OF ELECTRO CAUTERY AROUND THE SKULL BASE WAS A CONTRIBUTING FACTOR, OR THE MAIN FACTOR. NO FLUID WAS LEAKING WHEN MEDTRONIC DEVICES WERE USED, AND IT WAS REPORTED LEAKING OCCURRED AFTER THE CAUTERY WAS USED. ONE WEEK FOLLOWING THE PROCEDURE, THE SURGEON STATED THAT THE PATIENT WAS DOING FINE. RETURN REQUESTED. REPLACEMENT COMPUTER WAS SHIPPED TO SITE, HOWEVER, WAS RETURNED TO MANUFACTURER UNUSED. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS. NO FURTHER ISSUES HAVE BEEN REPORTED. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S FUSION NAVIGATION SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REPRESENTATIVE REPORTED THAT, WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE SURGEON IDENTIFIED A CEREBROSPINAL FLUID (CSF) LEAK. THE SURGEON WAS USING ELECTROCAUTERY FOR HEMOSTASIS ON TISSUE. FUSION WAS IN OR. NO FURTHER DETAILS REGARDING THIS ISSUE, OR SPECIFICALLY WHEN IT OCCURRED, WERE PROVIDED. THE SURGEON OPTED TO CONTINUE AND COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. DELAY IN THERAPY WAS LESS THAN ONE HOUR. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S FUSION NAVIGATION SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794658 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION 00613994380005

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention