BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEEP BRAIN STIMULATOR

    MDR report key: 1168342 · Received September 19, 2008

    Report

    Report Number
    2182207-2008-05867
    Event Type
    Death
    Date Received
    September 19, 2008
    Report Date
    August 20, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: SOULAS T, GURRUCHAGA JM, PALFI S, CESARO P, NGUYEN JP, FENELON G. ATTEMPTED AND COMPLETED SUICIDES AFTER SUBTHALAMIC NUCLEUS STIMULATION FOR PARKINSON'S DISEASE. J NEUROL NEUROSURG PSYCHIATRY. 2008; 79 (8): 952-954. A HIGHER THAN EXPECTED FREQUENCY OF SUICIDE HAS BEEN REPORTED AMOUNT PATIENTS UNDERGOING SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (STN DBS) FOR ADVANCED PARKINSON'S DISEASE (PD). WE CONDUCTED A RETROSPECTIVE SURVEY OF 200 PATIENTS WITH PD WHO UNDERWENT STN DBS BETWEEN 1997 AND 2006. MANUFACTURE/MODEL OF DEVICES WAS NOT REPORTED. REPORTABLE EVENT: DURING THE STUDY PERIOD, SOME PATIENTS DEATHS, TWO DEATHS HAD AN UNDETERMINED CIRCUMSTANCES/CAUSE, (2 SUICIDES WILL BE DETAILED LATER), AND THE OTHER WERE NOT RELATED. (MASTER FILE).

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