BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2201184 · Received July 29, 2011

    Report

    Report Number
    1723170-2011-01254
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE REPORTED EVENT, THE INACCURACY DURING NAVIGATION WAS DUE TO IMPROPER SETUP OF THE REFERENCE FRAME BY THE OPERATOR, AND NOT A MALFUNCTION OF THE DEVICE. THE SURGEON WAS INFORMED OF THE RISKS, BUT CHOSE TO CONTINUE SURGERY BY PERIODICALLY CHECKING ACCURACY. THE SYSTEM BEHAVE AS DESIGNED. NO PARTS WERE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THEY WERE UNABLE TO NAVIGATE AFTER GOING STERILE WHEN IN A CRANIAL PROCEDURE. MEDTRONIC TECHNICAL SERVICES REPRESENTATIVE WALKED THROUGH TROUBLESHOOTING TO ENSURE THE REFERENCE FRAME WAS FULLY SEATED ONTO THE VERTEK ARM; IT WAS. PASSIVE PLANAR PROBE WAS HELD ON THE OPPOSITE SIDE OF THE REFERENCE FRAME FROM THE PT AND TRACKING WAS ENABLED. MEDTRONIC REPRESENTATIVE INFORMED RN THAT THE NON-STERILE REFERENCE FRAME USED DURING REGISTRATION WAS INCORRECTLY ATTACHED TO THE VERTEK ARM. SURGEON WAS ADVISED OF THE POTENTIAL INACCURACY INHERENT IN PLACING THE STERILE REFERENCE FRAME UPSIDE DOWN TO NAVIGATE; SURGEON ASSURED HE UNDERSTOOD THE RISKS AND WOULD NOT ASSUME ACCURACY WITHOUT CHECKING. MEDTRONIC REPRESENTATIVE REPORTED THE CASE WAS DELAYED APPROX 15 MINUTES DUE TO TROUBLESHOOTING AND NON-STERILE REFERENCE FRAME STERILIZATION. ISSUE WAS DISCOVERED POST-CRANIOTOMY AND PRE-CEREBRAL INCISION. SURGERY WAS COMPLETED WITH THE USE OF THE STEALTHSTATION TREON. 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 49 YR