BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 1970947 · Received January 5, 2011

    Report

    Report Number
    1723170-2011-00018
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Date of Event
    June 10, 2010
    Report Date
    June 10, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPUTER SOFTWARE PERFORMANCE TESTS CONDUCTED. EVALUATION CONCLUDED THE EVENT COULD NOT BE REPLICATED AND DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. POWER CORD RETURNED TO MANUFACTURER AND FOUND TO BE FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    SITE CONTACTED MEDTRONIC VIA TELEPHONE AND REPORTED THE NAVIGATION SYSTEM STOPPED TRACKING THE DEVICES DURING SURGERY. THE SITE RE-BOOTED THE SYSTEM AND WAS ABLE TO PROCEED WITH SURGERY WITHOUT ANY EFFECT ON PATIENT OR PLANNED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION TREON NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK