BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1432283 · Received August 4, 2009

    Report

    Report Number
    2182207-2009-05386
    Event Type
    Injury
    Date Received
    August 4, 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. PATIENTS WERE RECRUITED, AND SOME PATIENTS DID NOT PASS INITIAL SCREENING. A TOTAL PATIENTS WERE RANDOMIZED TO STN OR GPI DBS. FORTY-FIVE PATIENTS COMPLETED THE STUDY. REPORTABLE EVENT: FIVE CASES OF CONFUSION/DISORIENTATION/DIFFICULTY CONCENTRATING/DISTRACTIBILITY WERE REPORTED AND NOTED TO BE SERIOUS. NO TREATMENT OR OUTCOME WAS REPORTED. SEE LITERATURE ARTICLE ATTACHED TO MFR REPORT# 2182207200905291.

    Devices

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

    Patients

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