BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2072378 · Received April 8, 2011

    Report

    Report Number
    1723170-2011-00769
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT WHILE IN A CRANIAL SURGERY, THE SURGEON COMPLETED REGISTRATION AND WAS GETTING READY TO NAVIGATE WHEN HE RECEIVED A "CRITICAL INTERNAL ERROR." THEY STILL HAD THE CD FROM LOADING THE PATIENT EXAM IN THE SYSTEM AND THE MEDTRONIC REPRESENTATIVE EXPLAINED THAT THIS ERROR COULD OCCUR WHEN GOING TO THE ARCHIVE STEP AND HAVING A CD WITH DATA ALREADY ON IT. INSTRUCTED THEM TO REMOVE THE CD AND RE-BOOT THE SYSTEM. THE SITE WAS ABLE TO GET BACK TO THE NAVIGATE TASK. THE SURGEON CONTINUED THE PROCEDURE USING THE STEALTHSTATION. THERE WAS NO IMPACT ON THE PATIENT OUTCOME.

    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 60 YR