BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2942203 · Received February 4, 2013

    Report

    Report Number
    1723170-2013-00056
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 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

    THE PATIENT DEMOGRAPHIC INFORMATION IS UNKNOWN. NO DETAILED INFORMATION WAS PROVIDED REGARDING THE NATURE OF THE PATIENT INJURY, REPORTED AS [UNKNOWN FACTORS]. WE PRESUME SOME INTERVENTION MAY HAVE BEEN REQUIRED DUE TO THE MENTION OF THE PATIENT EYE. SITE DIRECTOR OF MATERIALS REQUESTED A USER MANUAL ON THEIR FUSION NAVIGATION SYSTEM ON (B)(4) 2013. A MEDTRONIC REPRESENTATIVE E-MAILED THE DOCUMENT TO THE SITE ON (B)(4) 2013. MEDTRONIC FOLLOW-UP WITH SITE CLINICAL REPRESENTATIVE STATED THAT SINCE THE TIME OF THIS EVENT, THREE OTHER SURGEONS HAVE USED THIS SYSTEM IN APPROXIMATELY 17 PROCEDURES WITHOUT ISSUE. IT IS THE UNOFFICIAL SITE OPINION THERE IS NO ISSUE WITH THIS SYSTEM. NO FURTHER DETAILS HAVE BEEN PROVIDED TO DATE. NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    SERIOUS INJURY WAS CHECKED IN THE INITIAL MDR, BUT THERE IS NO CONFIRMATION OR DETAIL PROVIDED FROM THE USER TO INDICATE THERE WAS ANY MORE THAN A MINOR INJURY TO THE EYE.(B)(4).

    Additional Manufacturer Narrative · 1

    APPROPRIATE CODES PROVIDED. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE ON (B)(4) 2013 IDENTIFIED A BENT STRAIGHT SUCTION. THE SUSPECT DEVICE WAS DISCARDED AND REPLACED WITH A NEW SUCTION. PREVENTATIVE MAINTENANCE WAS PERFORMED WITHIN THE WEEK AND VERIFIED THE SYSTEM WAS WORKING PROPERLY. NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REPRESENTATIVE RECEIVED A REPORT FROM THE SITE ENT COORDINATOR, ALLEGING A CALIBRATION ISSUE WITH THEIR FRAZIER SUCTION. IT WAS ALLEGED THAT THERE WAS AN INJURY TO A PATIENT'S EYE WHILE IN AN ENT PROCEDURE. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE FUSION NAVIGATION SYSTEM. THERE WERE NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46812 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1