BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 1994311 · Received January 14, 2011

    Report

    Report Number
    1723170-2011-00042
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 28, 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

    PT AGE AND WEIGHT INFO WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. BASED ON COMMENTS FROM HOSP, WHILE INITIAL REGISTRATION WAS COMPLETE, THE DR FELT INACCURATE NAVIGATION. HOWEVER, THE ALLEGED INACCURACY HAS NOT BEEN QUANTIFIED, BUT HAS BEEN REQUESTED. HALFWAY THROUGH THE CASE HE RE-REGISTERED WITH A DIFFERENT METHOD AND ACCURACY WAS ACCURATE. CASE WAS COMPLETED WITH NO HARM TO THE PT.

    Description of Event or Problem · 1

    A MEDTRONIC INC. REP REPORTED THAT THE DR FELT INACCURATE IN THE BEGINNING OF AN ENT CASE. THE DR RE-REGISTERED WITH THE SYSTEM HALF WAY THROUGH THE CASE IMPROVING ACCURACY USING A DIFFERENT REGISTRATION METHOD AND THE SYSTEM OPERATED AS DESIGNED. THE CASE PROCEEDED WITH NO IMPACT TO THE PT.

    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