BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 1961677 · Received December 28, 2010

    Report

    Report Number
    1723170-2010-00232
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PT WEIGHT UNAVAILABLE FROM HOSPITAL. PER THE REPORTED EVENT, STAFF AT THE SITE WAS PROVIDED WITH INSTRUCTIONS FROM TECHNICAL SERVICES THAT RESOLVED THE ISSUE AT THE TIME OF THE EVENT.

    Description of Event or Problem · 1

    A NURSE REPORTED INTERMITTENT TRACKING WITH THEIR INSTRUMENTS DURING AN ENT PROCEDURE WITH THE FUSION SYSTEM. FOLLOWING TROUBLESHOOTING, THE STAFF REMOVED A METAL OBJECT THAT WAS NEXT TO THE OPERATING ROOM BED AND THE SURGEON WAS ABLE TO CONTINUE THE SURGERY USING THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON THE PT OUTCOME.

    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 64 YR