BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2121755 · Received May 20, 2011

    Report

    Report Number
    1723170-2011-00983
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 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

    PER THE REPORTED EVENT, THE INACCURACY DURING NAVIGATION WAS DUE TO REFERENCE FRAME MOVEMENT CAUSED BY SKIN SHIFT OF THE PATIENT, AND NOT A MALFUNCTION OF THE DEVICE. THE SOFTWARE INVESTIGATION FOUND THAT THE SYSTEM BEHAVED AS DESIGNED. AN ALTERNATIVE OPTION TO SETUP THE PATIENT WAS PRESENTED TO THE SURGEON.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT AFTER GOING STERILE AND MAKING THE BONE FLAP IN AN AXIEM CRANIAL PROCEDURE (BI-CORONAL CRANI FOR CSF LEAK), THE PATIENT TRACKER MOVED DUE TO SKIN SHIFT AND CAUSE THE SYSTEM TO BE INACCURATE. THEY WERE IMMEDIATELY AWARE OF THE INACCURACY AND ABANDONED NAVIGATION; HOWEVER, THE SURGEON WAS MAINLY USING THE SYSTEM TO LOCALIZE HIS BONE FLAP WHICH HE WAS ABLE TO DO SUCCESSFULLY. THERE WAS NO IMPACT TO 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 24 YR