BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATOR

    MDR report key: 1159085 · Received September 12, 2008

    Report

    Report Number
    2182207-2008-05646
    Event Type
    Injury
    Date Received
    September 12, 2008
    Report Date
    August 15, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: YORK MK, DULAY M, MACIAS A, ET AL. COGNITIVE DECLINES FOLLOWING BILATERAL SUBTHALMIC NUCLEUS DEEP BRAIN STIMULATION FOR THE TREATMENT OF PARKINSON'S DISEASE. J NEUROL NEUROSURG PSYCHIATRY. 2008; 79(7): 789-795. WE INVESTIGATED THE COGNITIVE AND PSYCHIATRIC OUTCOME 6 MOS AFTER BILATERAL SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (DBS) FOR THE TREATMENT OF PARKINSON'S DISEASE (PD) USING A DISEASE CONTROL GROUP. PTS WHO UNDERWENT DBS WERE COMPARED WITH 28 MEDICALLY TREATED PTS WITH PD AT BASELINE AND AT 6 MOS FOR NEUROPSYCHOLOGICAL MEASURES. REPORTABLE EVENT: TWO ADDITIONAL PTS WHO UNDERWENT DBS DEMONSTRATED STATISTICALLY RELIABLE DECLINES ON TWO OR MORE COGNITIVE MEASURES 6 MOS FOLLOWING SURGERY. THESE TWO PTS DID NOT MEET CRITERIA FOR DEMENTIA AS THEIR SCORES ON THESE MEASURES REMAINED WITHIN THE INTACT RANGE FOR THEIR AGE. SEE MFR REPORT 2182207200805638.

    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 Other EXTENSION MODEL UNK N=2| LEAD MODEL UNK N=2| PROGRAMMER MODEL UNK N=1