BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1008133 · Received March 6, 2008

    Report

    Report Number
    2182207-2008-01095
    Event Type
    Injury
    Date Received
    March 6, 2008
    Report Date
    February 18, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL REFERENCE: TEMEL Y, WILBRINK P, DUITS A, ET AL. SINGLE ELECTRODE AND MULTIPLE ELECTRODE GUIDED ELECTRICAL STIMULATION OF THE SUBTHALAMIC NUCLEUS IN ADVANCED PARKINSONS DISEASE. NEUROSURGERY 2007;61 (5, SUPPL 2): 346-357.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: TEMEL Y, WILBRINK P, DUITS A, ET AL. SINGLE ELECTRODE AND MULTIPLE ELECTRODES GUIDED ELECTRICAL STIMULATION OF THE SUBTHALAMIC NUCLEUS IN ADVANCED PARKINSONS DISEASE. NEUROSURGERY 2007;61 (5, SUPPL 2): 346-357. THE ARTICLE DESCRIBES THE RESULTS OF A STUDY WHERE 55 PTS WERE TREATED FOR SYMPTOMS OF ADVANCED PARKINSONS DISEASE WITH BILATERAL DEEP BRAIN STIMULATION (DBS) OF THE SUBTHALAMIC NUCLEUS (STN). THE PURPOSE OF THE STUDY WAS TO EVALUATE INTRAOPERATIVE ELECTROPHYSIOLOGICAL TECHNIQUES RELATED TO MICROELECTRODE RECORDING TO DETERMINE IF THERE WAS ANY EFFECT ON PT OUTCOME. IN ONE GROUP OF PTS, A SINGLE MICROELECTRODE (NOT MEDTRONIC) WAS USED AND IN THE OTHER GROUP MULTIPLE (UP TO FIVE) MICROELECTRODES (NOT MEDTRONIC) WERE USED TO ESTABLISH THE BEST POSITION TO IMPLANT THE PERMANENT MEDTRONIC MODEL 3389 DBS LEADS. IN PTS WERE THE MULTIPLE MICROELECTRODE APPROACH WAS USED, THE RESULTS DEMONSTRATED SUBTLE DETERIORATION IN NEUROPSYCHOLOGICAL FUNCTIONS, PARTICULARLY IN MEMORY FUNCTION. THESE SUBTLE CHANGES IN NEUROPSYCHOLOGICAL FUNCTION WERE NOT DETERMINED TO BE SIGNIFICANT BASED ON INTERVIEWS WITH PTS AND PARTNERS. PTS WERE ASSESSED AT 3 MONTHS AND 12 MONTHS POST DBS SYSTEM PLACEMENT. ADDITIONAL COMPLICATIONS NOT SPECIFICALLY RELATED TO THE MICROELECTRODE TECHNIQUES WERE ALSO INCLUDED IN THE ARTICLE. ONE PT EXPERIENCED A PNEUMOENCEPHALUS AND DECREASE IN CONSCIOUSNESS FOR APPROX 40 MINS FOLLOWING SURGERY AND IMPROVED AT THE TIME OF THE POSTOPERATIVE CT SCAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other 3389 (N=1)| LEAD EXT (N=2)| IPG (N=1)