BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2081233 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00860
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    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 SOFTWARE INVESTIGATION, ADD'L TRAINING ON PROPER TECHNIQUE REQUIRED FOR SITE TO FEEL MORE COMFORTABLE WITH THE POINTMERGE REGISTRATION METHOD. NO IMPACT ON PT OUTCOME REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC REP REPORTED, THE SURGEON FELT INACCURATE DURING A CASE USING A POINTMERGE REGISTRATION WITH FIDUCIALS IN THE MACH CRANIAL APPLICATION ON THE TREON SYSTEM. THE SURGEON FELT LESS ACCURATE WITH POINTMERGE THAN WITH TRACER OR TOUCH-N-GO. THE SITE DOES NOT RECALL WHAT THEIR PREDICTED ACCURACY VALUE WAS OR IF THE INACCURACY WAS IN A SPECIFIC DIRECTION. THERE WAS NO IMPACT ON PT OUTCOME REPORTED.

    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