BEUDAMED
    FDA Adverse Event Other Summary report: N

    STEALTHSTATION TREON SYSTEM

    MDR report key: 1641275 · Received March 23, 2010

    Report

    Report Number
    1723170-2010-00012
    Event Type
    Other
    Date Received
    March 23, 2010
    Date of Event
    March 8, 2010
    Report Date
    March 19, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. REQUESTS HAVE BEEN MADE TO OBTAIN PATIENT INFORMATION AND WILL BE PROVIDED IN A FOLLOW-UP REPORT. INVESTIGATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    SITE LOADED A SAGITTAL DATASET TRANSFERRED OVER THE NETWORK. THE SCAN WAS FLIPPED. THE FLIP WAS NOT DISCOVERED AND THE PATIENT WAS OPERATED ON THE WRONG SIDE. THERE HAS BEEN NO ADVERSE EFFECT FOR THE PATIENT FROM THIS INCIDENT. THE PATIENT HAS TO UNDERGO A SECOND PROCEDURE ON THE CORRECT SIDE. PROCEDURE WAS A SURETRAK NAVIGATED ENDOSCOPIC INTRAVENTRICULAR TUMOR BIOPSY USING MEDTRONIC NAVIGATION'S CRANIAL SYSTEM PLUS SOFTWARE ON A STEALTHSTATION TREON SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON SYSTEM STEREOTAXIC SURGICAL SYSTEM (HAW) HAW MEDTRONIC NAVIGATION TREON NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention