BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 920872 · Received September 21, 2007

    Report

    Report Number
    2182207-2007-03031
    Event Type
    Injury
    Date Received
    September 21, 2007
    Report Date
    September 30, 2005
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: SMEDING, ET AL. "UNILATERAL PALLIDOTOMY VERSUS BILATERAL SUBTHALAMIC NUCLEUS STIMULATION IN PD." JOURNAL OF NEUROLOGY. 2005; 25(2): 176-182. THE ARTICLE COMPARED THE COGNITIVE AND BEHAVIORIAL EFFECTS OF UNILATERAL PALLIDOTOMY AND BILATERAL SUBTHALAMIC NUCLEUS (STN) STIMULATION ON 34 PATIENTS. THE PATIENTS WERE IMPLANTED WITH DBS LEADS (MODEL 3389) AND NEUROSTIMULATOR (MODELS ITREL II, SOLETRA, OR KINETRA,). REPORTABLE EVENT: 3389 LEADS (N=2)- ONE PATIENT DEVELOPED SEVERE CONFUSION AND COGNITIVE CHANGES POST DBS LEAD PLACEMENT SURGERY. CT SHOWED BOTH ELECTRODES HAD DISPLACED. NO NEW LESIONS WERE NOTED. BOTH ELECTRODES WERE REPOSITIONED AND THE PATIENT HAD GOOD RESULTS ON BOTH MOTOR FUNCTION AND NEUROPSYCHOLOGICAL EVALUATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION 3389 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R