BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1015662 · Received March 19, 2008

    Report

    Report Number
    2182207-2008-01371
    Event Type
    Injury
    Date Received
    March 19, 2008
    Report Date
    November 2, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: PIBOOLNURAK ET AL. "LEVODOPA RESPONSE IN LONG-TERM BILATERAL SUBTHALAMIC STIMULATION FOR PARKINSON'S DISEASE" MOVEMENT DISORDERS/2007/22/7/990-997. THIS ARTICLE DESCRIBES A LONG-TERM FOLLOW-UP OF 33 PTS WITH DBS THERAPY FOR PARKINSON'S DISEASE. REPORTABLE EVENT: THERE WAS A TOTAL OF 2 ADVERSE EVENT REPORTS OF FREEZING OF GAIT DURING THE FOLLOW-UP. NO ADD'L INFO OR OUTCOMES WERE 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 Other LEAD MODEL 3387 N=1| EXTENSION MODEL UNK N=2| PROGRAMMER MODEL UNK N=1| IMPLANTABLE STIMULATOR MODEL UNK N=1