BEUDAMED
    FDA Adverse Event Summary report: N

    DEEP BRAIN STIMULATION DEVICES

    MDR report key: 921657 · Received September 21, 2007

    Report

    Report Number
    2182207-2007-03039
    Date Received
    September 21, 2007
    Report Date
    May 21, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: TARSY, MD, ET AL. "PROGRESSION OF PARKINSON'S DISEASE FOLLOWING THALAMIC DEEP BRAIN STIMULATION FOR TREMOR." STEREOTACTIC AND FUNCTIONAL NEUROSURGERY. 2005; 83: 222-227. THE ARTICLE DESCRIBES A STUDY ASSESSING THE LONG-TERM EFFECT OF THALAMIC DBS IN 17 PATIENTS BEING TREATED WITH DBS FOR SYMPTOMS RELATED TO PARKINSONS DISEASE. REPORTABLE EVENTS: THE 7424 IPG (N=1), 3387 LEAD (N=1) - ONE PATIENT EXPERIENCED DYSARTHRIA. THE 3387 LEAD (N=1) - ONE PATIENT EXPERIENCED PERSISTENT PARESTHESIA IN INDEX FINGER AND THUMB. THE 3387 LEAD (N=1) - ONE PATIENT EXPERIENCED A SCALP INFECTION REQUIRING LEAD REMOVAL. THE 7424 IPG (N=1) - ONE PATIENT EXPERIENCED AN IPG SITE WOUND INFECTION. THE 3387 LEAD (N=2) - TWO PATIENTS EXPERIENCED APPARENT MICROTHALAMOTOMY EFFECTS POST LEAD PLACEMENT. THE 7424 IPG (N=2) - ONE PATIENT RECEIVING TREATMENT USING BILATERAL DBS EXPERIENCED DYSARTHRIA WHICH WAS CORRECTED WITH ADJUSTMENTS TO THE IPG STIMULATION PARAMETERS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR