BEUDAMED
    FDA Adverse Event Summary report: N

    DEEP BRAIN STIMULATION DEVICES

    MDR report key: 921681 · Received September 21, 2007

    Report

    Report Number
    2182207-2007-03000
    Date Received
    September 21, 2007
    Report Date
    September 29, 2006
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: PARRA, J ET AL. "SERIOUS RESTLESS LEGS SYNDROME AFTER BILATERAL SUBTHALAMIC STIMULATION FOR TREATMENT OF A FEMALE PT WITH PARKINSON'S DISEASE." REVENUROL 2006; 42(12): 766. THE ARTICLE LISTS INFORMATION SUGGESTING A FEMALE PT BEING TREATED WITH DBS FOR SYMPTOMS ASSOCIATED WITH PARKINSONS DISEASE DEVELOPED RESTLESS LEG SYNDROME 20 DAYS POST BILATERAL DBS LEAD PLACEMENT SURGERY. SYMPTOMS DETERIORATED THE PTS QUALITY OF LIFE, LED TO DEPRESSION AND RESULTED IN A NUMBER OF ER ADMISSIONS. THE PT WAS TREATED WITH TRAMADOL AND REPIRINOL. AUTHOR INDICATES THAT THE DECREASE IN DOPAMINERGIC MEDICATION WITH THE USE OF DBS MAY HAVE CONTRIBUTED TO THE PTS RLS CONDITION. REPORTABLE EVENTS: DBS IPG (STIMULATOR) - PT DEVELOPED RESTLESS LEG SYNDROME WITH DEPRESSION. DBS LEAD (N=2) - PT DEVELOPED RESTLESS LEG SYNDROME WITH DEPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION DEVICES MHY MEDTRONIC NEUROMODULATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention| S