BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 982850 · Received January 22, 2008

    Report

    Report Number
    2182207-2008-00365
    Event Type
    Injury
    Date Received
    January 22, 2008
    Report Date
    January 3, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: KELLY VE, SAMII A, SLIMP JC, PRICE R, GOODKIN R, SHUMWAY-COOK A. GAIT CHANGES IN RESPONSE TO SUBTHALAMIC NUCLEUS STIMULATION IN PEOPLE WITH PARKINSON DISEASE: A CASE SERIES REPORT. J NEUROL PHYS THER. 2006; 30(4): 184-194. THE ARTICLE DESCRIBES THE RESULTS FROM A CASE SERIES THAT INVOLVED 6 PTS BEING TREATED WITH DEEP DRAIN STIMULATION (DBS) OF THE SUBTHALAMIC NUCLEUS FOR MANAGEMENT OF ADVANCED PARKINSON DISEASE. THE GOAL OF THE STUDY WAS TO EVALUATE THE EFFECTS OF UNILATERAL AND BILATERAL STIMULATION ON GAIT FOLLOWING STAGED STIMULATOR IMPLANTS. THREE PTS EXPERIENCED WORSENING GAIT FOLLOWING BILATERAL STIMULATION. A FEMALE PT (3) EXPERIENCED A POST SURGERY (UNILATERAL AND BILATERAL) SLIGHTLY WORSENING OF MOBILITY (WALKING DIFFICULT). GAIT VELOCITY DECREASED WITH BILATERAL STIMULATION. TREATMENT AND OUTCOME INFO WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION 3387 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other DBS LEAD MODEL 3387 (N=1)| LEAD EXTENSIONS UNK (N=2)| SOLETRA MODEL 7426 (N=2)