BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2060820 · Received March 11, 2011

    Report

    Report Number
    1723170-2011-00632
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT AVAILABLE AT TIME OF THIS REPORT. SOFTWARE INVESTIGATION COMPLETED. RADIOLOGY DEPARTMENT WAS ADVISED TO USE SAME SLICE THICKNESS FOR MULTIPLE EXAMS IF THEY WILL BE MERGED. SITE WAS INSTRUCTED ON HOW TO POINT MERGE TWO EXAMS EVEN IF THEY DON'T HAVE MATCHING SLICE THICKNESS. SOFTWARE FUNCTIONING AS DESIGNED.

    Description of Event or Problem · 1

    A NURSE, WHILE IN A CRANIAL SURGERY, REPORTED THAT THE T1 AND T2 WERE NOT LINED UP ON AUTO-MERGE. SHE DID AUTO-MERGE A FEW TIMES AND SAID WHEN SHE DID THE CONTRAST, THEY DID NOT LOOKED LINED UP. A MEDTRONIC REPRESENTATIVE WALKED THE SITE THROUGH TROUBLESHOOTING AND WAS ABLE TO SEE WHAT HE NEEDED TO SEE IN THE T1 ONLY AND CONTINUED THE CASE WITH NO IMPACT TO THE PATIENT.

    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 UNK