BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2040346 · Received February 15, 2011

    Report

    Report Number
    1723170-2011-00654
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INFO AS NO PT WAS INVOLVED IN THIS CONCERN. DEVICE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED A COMMS CABLE FAULT FOR AXIEM. SURGEON ALLEGES THAT THE AXIEM FREEZES AND THEY HAVE TO MESS AROUND WITH THE COMMS CABLE TO UNFREEZE THE SOFTWARE. THERE WAS NO PT PRESENT.

    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