BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 949273 · Received November 15, 2007

    Report

    Report Number
    2182207-2007-03817
    Event Type
    Injury
    Date Received
    November 15, 2007
    Report Date
    October 14, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    JOURNAL REFERENCE: CHUNG, ET AL. " BILATERAL EFFECTS OF UNILATERAL SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION IN ADVANCED PARKINSON'S DISEASE." EUR NEUROL 2006, 56: 127-132. THE ARTICLE DESCRIBES THE RESULTS OF A PROSPECTIVE STUDY OF CONSECUTIVE PATIENTS BEING TREATED WITH UNILATERAL DEEP BRAIN STIMULATION FOR PARKINSONS DISEASE SYMPTOMS. PATIENTS WERE EVALUATED AT 3 AND 6 MONTHS. A NUMBER OF PATIENT COMPLICATIONS WERE REPORTED. REPORTABLE EVENT: ONE PATIENT EXPERIENCED BEHAVIOR CHANGES, TO INCLUDE DISINHIBITION AND MANIC STATE, POST RIGHT SIDE STN-DBS LEAD IMPLANT. 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 3389 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other LEAD EXTENSIONS (1)| IMPLANTABLE NEUROSTIMULATOR (MODEL 7426)