BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAJECTORY GUIDE KIT

    MDR report key: 3840817 · Received May 23, 2014

    Report

    Report Number
    MW5036360
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MEDTRONIC NAVIGATION INC.
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC TRAJECTORY GUIDE KIT, EXTERNAL BIOPSY GUIDE WAS TOO TIGHT, THEREBY NOT ALLOWING FOR EFFECTIVE UTILIZATION. REPLACED WITH "LIKE" DEVICE WHICH FUNCTIONED WITHOUT PROBLEM. DIAGNOSIS OR REASON FOR USE: BRAIN BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307103 TRAJECTORY GUIDE KIT NONE HAW MEDTRONIC NAVIGATION INC. 9733065 066204914

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR