BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2110031 · Received May 17, 2011

    Report

    Report Number
    1723170-2011-00974
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 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

    PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. DEVICE MANUFACTURE DATE NOT AVAILABLE AT TIME OF THIS REPORT. INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT WHILE IN A CRANIAL PROCEDURE, THE TOUCH-N-GO REGISTRATION WOULD NOT WORK. THE MEDTRONIC REP STATED THAT THE FUDICIAL PLACEMENT WAS VERY SYMMETRICAL BUT NOT COMPLETELY. AFTER THEY REGISTERED WITH THE TRACER THE IMAGE WAS FLIPPED. THE PREDICTED ACCURACY WAS 2.2. THE SURGEON DID POINTMERGE NEXT AND WAS ABLE TO USE THE REGISTRATION TO CONTINUE WITH SURGERY USING THE STEALTHSTATION. THERE WAS NO IMPACT ON THE PT 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 52 YR