BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2161874 · Received July 8, 2011

    Report

    Report Number
    1723170-2011-01203
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SOFTWARE HAS NOT BEEN EVALUATED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REPRESENTATIVE REPORTED THAT THE SITE ALLEGED THEIR FUSION SYSTEM WAS INACCURATE DURING AN ENT CASE. THE SURGEON REPORTED THAT HE TESTED FOR ACCURACY ON ANATOMICAL LANDMARKS AT THE BEGINNING OF NAVIGATION AND WAS ACCURATE. IT WAS NOT UNTIL THE END OF THE CASE THAT HE STATED THERE WAS A SIGNIFICANT INACCURACY. THE SURGERY WAS COMPLETED WITH THE USE OF THE FUSION NAVIGATION SYSTEM. THE PT DEVELOPED A CEREBRAL SPINE FLUID LEAK AFTER THE CASE AND HAD TO BE EMERGENCY TRANSPORTED TO THE HOSPITAL FROM THE SURGICAL CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION NAVIGATION SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. FUSION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention