BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 3090503 · Received May 2, 2013

    Report

    Report Number
    1723170-2013-00326
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED.A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE SYSTEM CHECKOUT SHOWED THAT THE SYSTEM WAS FULLY FUNCTIONAL. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL.

    Description of Event or Problem · 1

    A SURGEON REPORTED A 1CM INACCURACY AFTER REGISTRATION. HE DID NOT RE-REGISTER. THERE WAS NO KNOWN IMPACT TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191816 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1