BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEEP BRAIN STIMULATOR

    MDR report key: 1425504 · Received July 30, 2009

    Report

    Report Number
    2182207-2009-05294
    Event Type
    Injury
    Date Received
    July 30, 2009
    Date of Event
    June 20, 2009
    Report Date
    July 17, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: OKUN MS, FERNANDEZ HH, WU SS, ET AL. COGNITION AND MOOD IN PARKINSON'S DISEASE IN SUBTHALAMIC NUCLEUS VERSUS GLOBUS PALLIDUS INTERNA DEEP BRAIN STIMULATION: THE COMPARE TRIAL. ANN NEUROL, 2009; 65(5): 586-595. SUMMARY: THE STUDY WAS A SINGLE-CENTER, PROSPECTIVE, RANDOMIZED, PATIENT-AND RATER-BLIND, PARALLEL-GROUP TRIAL THAT AIMED TO CHARACTERIZE AND COMPARE THE EFFECTS OF UNILATERAL STN AND UNILATERAL GPI DBS ON MOOD AND COGNITIVE FUNCTION IN PATIENTS WITH ADVANCED PD. SIXTY-TWO PATIENTS WERE RECRUITED, AND 10 PATIENTS DID NOT PASS INITIAL SCREENING. FIFTY-TWO PATIENTS WERE RANDOMIZED TO STN OR GPI DBS. FORTY-FIVE PATIENTS COMPLETED THE STUDY. REPORTABLE EVENT: ONE CASE OF SUICIDAL THOUGHTS WAS REPORTED. THE SYMPTOMS WERE NOT NOTED TO BE SERIOUS. NO TREATMENT OR OUTCOME WAS REPORTED. THE LEAD WAS IMPLANTED IN THE GPI. SEE LITERATURE ARTICLE ATTACHED TO MFR REPORT# 2182207200905291.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387