BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 977467 · Received January 10, 2008

    Report

    Report Number
    2182207-2008-00127
    Event Type
    Injury
    Date Received
    January 10, 2008
    Report Date
    November 2, 2007
    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

    JOURNAL REFERENCE: DAMIER ET AL. "BILATERAL DEEP BRAIN STIMULATION OF THE GLOBUS PALLIDUS TO TREAT TARDIVE DYSKINESIA" ARCH GEN PSYCHIATRY; 2007:64:170-176.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: DAMIER ET AL. "BILATERAL DEEP BRAIN STIMULATION OF THE GLOBUS PALLIDUS TO TREAT TARDIVE DYSKINESIA" ARCH GEN PSYCHIATRY; 2007:64:170-176. THE ARTICLE DESCRIBES THE RESULTS FROM A STUDY THAT INVOLVED A SERIES OF 10 PATIENTS TREATED WITH BILATERAL DEEP BRAIN STIMULATION (DBS) OF THE INTERNAL PART OF THE GLOBUS PALLIDUS FOR MANAGEMENT OF SYMPTOMS RELATED TO TARDIVE DYSKINESIA (TD). THE STUDY OBJECTIVE WAS TO ASSESS THE EFFICACY OF DBS TREATMENT. THE ARTICLE INCLUDED COMPLICATIONS RELATED TO DEEP BRAIN STIMULATION THERAPY. A FEMALE PATIENT (2) EXPERIENCED WORSENING DEPRESSED MOOD AT THE SIX MONTH FOLLOW-UP. THE CHANGE IN MOOD DID NOT MEET THE DSM-IV CRITERIA FOR MAJOR DEPRESSIVE DISORDER. ONE OF THREE PATIENTS (UNSPECIFIED) THAT EXPERIENCED A MOOD CHANGE, RECEIVED ANTI-DEPRESSIVE THERAPY.

    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 33 YR Other IPG MODEL 7428 (N=1)| LEAD EXTENSIONS (N=2)| DBS LEAD UNK (N=1)