BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 1994277 · Received January 14, 2011

    Report

    Report Number
    1723170-2011-00043
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WILL NOT BE PROVIDED BY SITE. A SOFTWARE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT WHILE REGISTERING A PT THE SOFTWARE HAD LOGGED ITSELF OUT. AFTER A COUPLE OF MINUTES HAD PASSED THEY WERE ABLE TO RE-REGISTER THE PT AND BEGIN THE PROCEDURE WITHOUT ANY FURTHER ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1