BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2121769 · Received May 20, 2011

    Report

    Report Number
    1723170-2011-00986
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 23, 2011
    Report Date
    April 23, 2011
    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

    THERE WAS NO PT PRESENT. THE RETURNED PRODUCT DID NOT MEET SPECIFICATIONS. THE DEVICE HAD AN ELECTRICAL MALFUNCTION THAT WAS CONFIRMED AND DIRECTLY RELATED TO THE REPORTED EVENT. THE PART WAS REPAIRED AT THE SITE AND THE ISSUE WAS RESOLVED. AFTER THE PART WAS REPAIRED, THE SYSTEM WAS FULLY FUNCTIONAL AND THE SYSTEM CHECKOUT SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WIRES WERE COMING OUT OF THE PLUG OF A NAVIGATION SYSTEM. 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