BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION TREATMENT GUIDANCE PLATFORM

    MDR report key: 262131 · Received February 14, 2000

    Report

    Report Number
    1723170-2000-00001
    Event Type
    Injury
    Date Received
    February 14, 2000
    Date of Event
    December 20, 1999
    Report Date
    February 9, 2000
    Manufacturer
    MEDTRONIC SURGICAL NAVIGATION
    Product Code
    HAW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 1999, A DOCTOR ATTEMPTED TO USE THE STEALTHSTATION TREATMENT GUIDANCE PLATFORM AS AN AID IN REMOVING A CRANIAL LESION. THE DOCTOR PERFORMED A FIRST REGISTRATION, THEN REMOVED THE SKIN AND BONE FLAPS. AT THIS POINT, IT WAS NOTICED THAT THE CRANIAL ARC HAD MOVED. IT APPEARS THAT THE ARC WAS NOT TIGHTENED SUFFICIENTLY. SINCE THE STEALTHSTATION SYSTEM REQUIRES THAT THE ARC REMAIN RIGID, THE DOCTOR COULD NOT PROCEED WITH THE ORIGINAL REGISTRATION. THE DOCTOR THEN PROCEEDED TO CLOSE THE SKIN AND BONE FLAPS, AND PERFORMED A SECOND REGISTRATION. AFTER DR PERFORMED THE SECOND REGISTRATION AND A SECOND LOCALIZATION, THE DOCTOR PROCEEDED WITH THE CASE. THE MEAN FIDUCIAL ERROR (MFE) WAS 3.3 MM, WITH A PREDICTED ACCURACY OF 2.1 MM. THE LESION WAS THOUGHT TO BE APPROX 2 CM UNDERNEATH THE DURA MATER AND APPROX 1.5 CM IN DIAMETER, HOWEVER, THE DOCTOR HAD DIFFICULTY LOCATING THE LESION. WHEN THE CASE WAS COMPLETED, THE DOCTOR REQUESTED AN ADDITIONAL SCAN AND REALIZED THAT THE LESION WAS STILL PRESENT. THE DOCTOR ALSO REALIZED THAT DURING THE COURSE OF SURGERY, THE MOTOR STRIP WAS HIT. THE PT IS NOW UNI-LATERAL HEMIPLEGIC ON THE RIGHT SIDE OF BODY (THE ENTIRE RIGHT SIDE OF THE BODY IS PARALYZED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREATMENT GUIDANCE PLATFORM IMAGE GUIDED STEREOTACTIC DEVICE HAW MEDTRONIC SURGICAL NAVIGATION STEALTHSTATION SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Disability