BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATOR

    MDR report key: 1159081 · Received September 12, 2008

    Report

    Report Number
    2182207-2008-05663
    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 SUBTHALAMIC 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 MONTHS AFTER BILATERAL SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (DBS) FOR THE TREATMENT OF PARKINSON'S DISEASE (PD) USING A DISEASE CONTROL GROUP. A TOTAL PTS WHO UNDERWENT DBS WERE COMPARED WITH MEDICALLY TREATED PTS WITH PD AT BASELINE, AND AT 6 MONTHS FOR NEUROPSYCHOLOGICAL MEASURES. REPORTABLE EVENT: ONE PT WHO DID NOT RETURN FOR THEIR 6 MONTH FOLLOW-UP DUE TO PSYCHOLOGICAL DISTRESS WAS NOT INCLUDED IN THESE ANALYSES. THIS PT WAS A MAN WHO DENIED DEPRESSION AT BASELINE, BUT REPORTED EXPERIENCING A SINGLE BOUT OF DEPRESSION, AMELIORATED WITH PSYCHOTROPIC MEDICATION, IMMEDIATELY AFTER HE WAS DIAGNOSED WITH PD 19 YEARS EARLIER. THIS PT REFUSED TO PARTICULATE IN HIS 6 MONTH FOLLOW-UP; HIS FAMILY DESCRIBED HIM AS "DEPRESSED AND INACTIVE". SEE MFG 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 70 YR Other PROGRAMMER MODEL UNK N=1| EXTENSION MODEL UNK N=2| LEAD MODEL UNK N=2