BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEEP BRAIN STIMULATOR

    MDR report key: 1168356 · Received September 19, 2008

    Report

    Report Number
    2182207-2008-05868
    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

    Additional Manufacturer Narrative · 1

    .

    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 AMONG PATIENTS UNDERGOING SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (STN DBS) FOR ADVANCED PARKINSON'S DISEASE (PD). WE CONDUCTED A RETROSPECTIVE SURVEY OF A TOTAL PATIENTS WITH PD WHO UNDERWENT STN DBS BETWEEN 1997 AND 2006. MANUFACTURER/MODEL OF DEVICES WAS NOT REPORTED. REPORTABLE EVENT: PATIENT, MALE COMMITTED SUICIDE 5 MONTHS AFTER DBS. THE APPARENT TRIGGER WAS MILD ANNOYANCE AT HOME. DEATH BY DROWNING. SEE MFG REPORT 218220720005867.

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