BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 3913998 · Received July 3, 2014

    Report

    Report Number
    1723170-2014-00721
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE AND SURGEON HAVE COMPLETED 5 SUCCESSFUL SURGERIES SINCE THE REPORTED ISSUE. ALL PASSED TRACER REGISTRATION SUCCESSFULLY. ACCURACY WAS GOOD THROUGHOUT ALL CASES. SYSTEM FUNCTIONING NORMALLY.

    Additional Manufacturer Narrative · 1

    THE NURSE MANAGER AT THE SITE DECLINED TO PROVIDE PATIENT DEMOGRAPHIC INFORMATION. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE THE DAY OF AND THE DAY AFTER THE SURGERY TO TEST THE EQUIPMENT. THE REP CHECKED THE SYSTEM WITH A MODEL HEAD AND OPENED ALL OF THEIR TWO SETS OF INSTRUMENTS. THE SYSTEM AND ALL INSTRUMENTS PERFORMED NORMALLY, AND THE STRAIGHT SUCTIONS CALIBRATED WITH NO DIFFICULTY. THE SYSTEM PERFORMED AS INTENDED AND THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. THE SCAN HAD OVER 150 SLICES, AND WAS DONE TO SCAN PROTOCOL PARAMETERS. THE ACCOUNT DID NOT ALLOW THE REP TO GATHER, RECORD OR REPORT ANY MORE INFORMATION ON THE PATIENT OR PROCEDURE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED AN ALLEGED INACCURACY FROM THE SITE. THE SITE TOLD HIM THAT DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE WHILE NAVIGATING THE STRAIGHT SUCTION, THE SURGEON PUNCTURED THE DURA. THE SURGEON ALLEGED A 5MM INACCURACY OF THE STRAIGHT SUCTION INSTRUMENT. THE PATIENT PRESENTED WITH A CSF LEAK THAT WAS DETECTED DURING THE SURGERY, AND THE PROCEDURE WAS DELAYED TWENTY TO THIRTY MINUTES TO REPAIR THE LEAK. THE SURGERY WAS COMPLETED WITH THE USE OF THE NAVIGATION SYSTEM. THE ONSITE RNS WERE NOT WILLING TO GIVE OUT ANY FURTHER PATIENT OR SURGICAL INFORMATION PER HOSPITAL PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390938 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention