BEUDAMED
    FDA Adverse Event Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 3122813 · Received May 21, 2013

    Report

    Report Number
    1723170-2013-00363
    Date Received
    May 21, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ORIGINALLY FILED AGAINST THE SYSTEM SUBCOMPONENT MOBILE EMITTER FIELD GENERATOR, BUT HAS NOW BEEN CORRECTED TO THE ACTUAL NAVIGATION SYSTEM. CORRECTED MODEL AND CATALOGUE NUMBER PROVIDED. SERIAL NUMBER NOW PROVIDED. MANUFACTURE DATE NOW PROVIDED. THE SUSPECT EMITTER WAS RETURNED FOR EVALUATION. DURING PERFORMANCE TESTING THE EMITTER WAS FOUND FULLY FUNCTIONAL. AFTER REPLACING THE EMITTER IN THE SYSTEM IN THE FIELD THE SYSTEM TESTED FULLY FUNCTIONAL. UNABLE TO DETERMINE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. DEVICE LOT NUMBER, OR SERIAL NUMBER, NOT AVAILABLE AT TIME OF THIS REPORT. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SN, THEREFORE, UNAVAILABLE AT THIS TIME. RMA ISSUED. REPLACEMENT EMITTER SHIPPED TO SITE (B)(4) 2013. SUSPECT DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A SITE BIOMED REPRESENTATIVE REPORTED A PROBLEM WITH THE SYSTEM EMITTER TRACKING PROPERLY AND REQUESTED A REPLACEMENT BEFORE USING IT IN SURGICAL PROCEDURES AT A LATER DATE. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224401 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other