BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL II

    MDR report key: 1162718 · Received September 16, 2008

    Report

    Report Number
    2182207-2008-05821
    Event Type
    Injury
    Date Received
    September 16, 2008
    Report Date
    August 20, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGES.

    Description of Event or Problem · 1

    LIND G, SCHECHTMANN G, LIND C, WINTER J, MEYERSON BA, LINDEROTH B. SUBTHALAMIC STIMULATION FOR ESSENTIAL TREMOR, SHORT-AND LONG-TERM RESULTS AND CRITICAL TARGET AREA. STEREOTACT FUNCT NEUROSURG. 2008;86(4):253-258. IN ORDER TO EXPLORE THE USEFULNESS AND LONG-TERM RESULTS OF SUBTHALAMIC NUCLEUS (STN) STIMULATION FOR THE TREATMENT OF ESSENTIAL TREMOR (ET), WE EVALUATED 3 GROUPS OF PATIENTS UNDERGOING DEEP BRAIN STIMULATION (DBS) FOR ET. GROUP 1 CONSISTED OF 3 PATIENTS WHO 9 YEARS AGO AT INTRA-OPERATIVE TESTING HAD GOOD TEMOR REDUCTION FROM STN STIMULATION. THE SECOND GROUP CONSISTED OF 10 PATIENTS TREATED WITH DBS IN THE VENTRAL INTERMEDIATE (VIM) NUCLEUS OF THE THALAMUS. THE THIRD GROUP COMPRISED 9 PATIENTS SUBJECTED TO STN STIMULATION FOR ET WITH 1-3 YEARS OF FOLLOW-UP. REPORTABLE EVENT: GROUP 2. ONE PATIENT HAD HAD SEVERAL BATTERY REPLACEMENTS, AND DESPITE AN INCREASE IN STIMULATION INTENSITY, THE TREMOR-BLOCKING EFFECT HAD DIMINISHED CONSIDERABLY. THE ELECTRODE WAS EVENTUALLY REMOVED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL II MHY MEDTRONIC NEUROMODULATION 7424 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R LEAD MODEL 3387 N=1| PROGRAMMER MODEL UNK N=1