BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 981600 · Received January 17, 2008

    Report

    Report Number
    2182207-2008-00311
    Event Type
    Injury
    Date Received
    January 17, 2008
    Report Date
    January 3, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED FROM THE USER FACILITY; THEREFORE, INFO ON THE MEDWATCH FORM 3500A WAS COMPLETED BY MEDTRONIC WITH INFO FROM THE ARTICLE.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: FUNKIEWIEZ A, ARDOUIN C, COOLS R, ET AL. EFFECTS OF LEVODOPA AND SUBTHALAMIC NUCLEUS STIMULATION ON COGNITIVE AND AFFECTIVE FUNCTIONING IN PARKINSONS DISEASE. MOV DISORD. 2006; 21(10): 1656-1662. THE ARTICLE DESCRIBES THE RESULTS FROM A STUDY THAT INVOLVED A SERIES OF 22 PTS BEING TREATED WITH BILATERAL DEEP DRAIN STIMULATION (DBS) FOR MANAGEMENT OF SYMPTOMS RELATED TO PARKINSONS DISEASE. THE STUDY OBJECTIVE WAS TO ASSESS COGNITION BEHAVIOR AND MOOD WITH STIMULATION ON AND OFF. PTS WERE TESTED PRIOR 2 AND 3 MONTHS AFTER SURGERY. FIVE PTS WERE DETERMINED TO BE APATHETIC AT THREE MONTHS POST SURGERY. TREATMENT (IF ANY) AND OUTCOME INFO WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Other LEAD EXTENSIONS (N=2)| IPG SINGLE OUTPUT (2)| LEAD UNK (N=1)| IPG DUAL OUTPUT UNK (N=1)