BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2081218 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00864
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MENT REP WAS AT SITE AND TESTED THE SYSTEM AND CONNECTED EVERYTHING AND WAS UNABLE TO REPLICATE THE ISSUE.

    Description of Event or Problem · 1

    MEDTRONIC ENT REP REPORTED AN EMITTER ERROR, ON THE INFUSION NAVIGATION SYSTEM, WHILE SURGEON WAS USING SYSTEM. NO IMPACT ON PT OUTCOME REPORTED.

    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 UNK