BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2883909 · Received December 21, 2012

    Report

    Report Number
    1723170-2012-00767
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE SOFTWARE INVESTIGATION, NO SOFTWARE FAULTS OR ANOMALIES WERE FOUND TO BE THE CAUSE OF THE ALLEGED INACCURACY. UNABLE TO DETERMINE ROOT CAUSE WITH INFORMATION PROVIDED. IT IS SUSPECTED THAT A CHANGE IN ANATOMY DUE TO SEPTOPLASTY BEING PERFORMED CAUSED THE ANATOMY TO NO LONGER MATCH THE PATIENT'S SCAN.

    Additional Manufacturer Narrative · 1

    NO FILES HAVE BEEN RECEIVED BY THE MANUFACTURER FOR INVESTIGATION. SOFTWARE HAS NOT BEEN EVALUATED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THE SITE ALLEGED THEIR FUSION NAVIGATION SYSTEM WAS INACCURATE 3-4 MM. THEY RE-REGISTERED THE PATIENT, BUT STILL FELT INACCURATE. THE SURGEON PROCEEDED WITH THE CASE AND COMPLETED WITH THE USE OF NAVIGATION. NO NEGATIVE IMPACT TO THE PATIENT OUTCOME WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR