BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 978828 · Received January 11, 2008

    Report

    Report Number
    2182207-2008-00181
    Event Type
    Injury
    Date Received
    January 11, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: ONDO ET AL. "SUBTHALAMIC DEEP BRAIN STIMULATION IN PATIENT'S WITH A PREVIOUS PALLIDOTOMY" MOVEMENT DISORDERS/2006/21/8/1252-1254. THE ARTICLE DESCRIBES THE RESULTS FROM A STUDY THAT INVOLVED A SERIES OF 10 PATIENT'S TREATED WITH DEEP BRAIN STIMULATION (DBS) OF THE SUBTHALAMIC NUCLEUS (STN) FOR MANAGEMENT OF SYMPTOMS RELATED TO PARKINSONS DISEASE. THE DBS SYSTEMS USED INCLUDED 1 UNILATERAL AND 9 BILATERAL. PRIOR TO THE DBS TREATMENT THE STUDY PATIENTS HAD ALL RECEIVED UNILATERAL PALLIDOTOMY TREATMENT. THE CONTROL GROUP WAS MADE UP OF 25 PATIENT TREATED WITH DEEP BRAIN STIMULATION (DBS) OF THE SUBTHALAMIC NUCLEUS (STN) THAT HAD NOT RECEIVED PALLIDOTOMY TREATMENT. THE STUDY OBJECTIVE INVOLVED THE ASSESSMENT OF THE SAFETY AND EFFICACY OF THE PALLIDOTOMY WITH STN DBS THERAPY. THE ARTICLE INCLUDED A NUMBER OF COMPLICATIONS, FROM BOTH GROUPS, RELATED TO DEEP BRAIN STIMULATION THERAPY. REPORTABLE EVENT: ONE PATIENT (LEAD N=1) IN THE CONTROL GROUP EXPERIENCED A LEAD INFECTION. TREATMENT AND OUTCOME INFORMATION 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 Required Intervention SYSTEM NOT SPECIFIED.| SINGLE OUTPUT IPG (N=2) OR DUAL OUTPUT IPG (N=1).| UNILATERAL SYSTEM: LEAD EXTENSIONS(N=1)| BILATERAL SYSTEM: LEAD EXTENSIONS (N=2)| DBS LEAD UNK (N=1)