BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2061569 · Received March 16, 2011

    Report

    Report Number
    1723170-2011-00669
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 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

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS PRESENT. DEVICE MANUFACTURE DATE NOT AVAILABLE AT THIS TIME. THE SYSTEM WAS EVALUATED AT THE SITE. THE REPORTED ISSUE WAS FOUND TO BE DIRECTLY RELATED TO A LOOSE MONITOR CABLE. THE CABLE WAS SECURED AND THE ISSUE WAS RESOLVED. THERE WERE NO FURTHER ISSUES.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THE STEALTHSTATION TREON SYSTEM POWERED OFF ON ITS OWN. THE SITE REPORTS THAT THEY ALWAYS KEEPS THE SYSTEM ON AND IT TURNED OFF MORE THAN ONCE AT RANDOM TIMES. THE SYSTEM DID NOT TURN OFF DURING USE. THERE WAS NO PATIENT 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