BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATOR

    MDR report key: 1209591 · Received October 23, 2008

    Report

    Report Number
    2182207-2008-06827
    Event Type
    Injury
    Date Received
    October 23, 2008
    Report Date
    September 25, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: LLUMIGUANO C, KOVACS N, USPRUNG ZS, SCHWARCZ A, DOCZI TP, BALAS I, 1H-MRS EXPERIENCES AFTER BILATERAL DBS OF THE STN IN PARKINSON'S DISEASE. PARKINSONISM RELAT DISORD. 2008;14(3):229-232. THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE CHANGES IN THE CONCENTRATIONS OF CERTAIN BRAIN METABOLITES IN 13 PTS WITH PARKINSON'S DISEASE BEFORE AND AFTER BILATERAL SUBTHALAMIC NUCLEUS (STN DBS). WE HAVE DEMONSTRATED THAT CORTICAL (LFBC) NAA/CHO AND NAA/CR RATIOS WERE SIGNIFICANTLY INCREASED PAIRED WITH THE SIGNIFICANT DECREASE OF CHO/CR RATIO IN ALL PTS TREATED WITH STN DBS. AN INSIGNIFICANT DECREASE OF THE NAA/CHO RATION WAS OBSERVED IN THE SELECTED VOXELS IN GP. REPORTABLE EVENT: IN ONE CASE SEROMA IN THE IMPLANTED IPG SITE DEVELOPED FOLLOWING STN DBS IMPLANTATIONS. SEE MFG REPORT#: 2182207-2008-06825.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other LEAD MODEL UNK N=2| PROGRAMMER MODEL UNK N=1| EXTENSION MODEL UNK N=2