BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2153272 · Received June 30, 2011

    Report

    Report Number
    1723170-2011-01146
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDS THIS PATIENT WILL BE SCHEDULED FOR A SECOND SURGERY. SOFTWARE HAS NOT BEEN EVALUATED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A SAGITTAL SCAN WAS IMPORTED FROM THE PLANNING STATION TO THE STEALTHSTATION TREON GUIDANCE SYSTEM. THE ORIENTATION IN THE LEFT-RIGHT DIRECTION WAS INVERTED AND THIS WAS NOT SEEN OR CORRECTED BY THE SURGEON, LEADING TO A SURGERY ON THE WRONG SIDE OF 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 48 YR Required Intervention