BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEEP BRAIN STIMULATION DEVICE

    MDR report key: 921665 · Received September 21, 2007

    Report

    Report Number
    2182207-2007-03051
    Event Type
    Other
    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
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: CHOU, ET AL. "ELECTROCONVULSIVE THERAPY FOR DEPRESSION IN A PARKINSON'S DISEASE PT WITH BILATERAL SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATOR." PARKINSONISM AND RELATED DISORDERS. 2005; 11(6): 403-406. SEVERAL STUDIES HAVE SUGGESTED THAT STN STIMULATION CAN BE ASSOCIATED WITH DELETERIOUS EFFECTS ON MOOD, ESPECIALLY DEPRESSION. IN MANY CASES, DEPRESSIVE SYMPTOMS OCCUR WITHIN A MONTH POST-OPERATIVELY AND RESOLVE EITHER WITHOUT SPECIFIC THERAPY OR WITH MINOR STIMULATOR ADJUSTMENTS. THIS ARTICLE SUGGESTS THAT ECT CAN BE A SAFE AND EFFECTIVE OPTION FOR SEVERE DEPRESSION IN PD PTS TREATED WITH STN DBS. REPORTABLE EVENT: UNK DBS LEADS (N=2) - A FEMALE PT WITH ADVANCED PARKINSONS DISEASE DEVELOPED A RECURRENCE OF MAJOR DEPRESSIVE WITH PSYCHOTIC FEATURES AFTER BILATERAL SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) SURGERY. ELECTROCONVULSIVE THERAPY (ECT) DRAMATICALLY IMPROVED THE DEPRESSION WITHOUT SHIFTING ELECTRON POSITION OR DAMAGING THE DBS HARDWARE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR