BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEEP BRAIN STIMULATOR

    MDR report key: 1159260 · Received September 12, 2008

    Report

    Report Number
    2182207-2008-05671
    Event Type
    Death
    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
    OTHER

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: YORK MK, DULAY M, MACIAS A, ET AL. COGNITIVE DECLINED 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. TWENTY THREE PATIENTS WHO UNDERWENT DBS WERE COMPARED WITH 28 MEDICALLY TREATED PATIENTS WITH PD AT BASELINE AND AT 6 MONTHS FOR NEUROPSYCHOLOGICAL MEASURES. REPORTABLE EVENT: ONE PATIENT WHO DID NOT RETURN FOR THEIR 6 MONTH FOLLOW-UP DUE TO PSYCHOLOGICAL DISTRESS WAS NOT INCLUDED IN THESE ANALYSES. THE FIRST PATIENT WAS A MAN, DIAGNOSED WITH PD 7 YEARS EARLIER, WHO COMMITTED SUICIDE 4 MONTHS AFTER HIS DBS SURGERY. HE DID NOT HAVE A HISTORY OF PSYCHOLOGICAL DISTRESS OR SUICIDAL IDEATION PRIOR TO SURGERY. 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 53 YR Death| O LEAD MODEL UNK N=2| EXTENSION MODEL UNK N=2| PROGRAMMER MODEL UNK N=1