BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 977466 · Received January 10, 2008

    Report

    Report Number
    2182207-2008-00116
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL REFERENCE: JOURNAL REFERENCE: COYNE ET AL. "RAPID SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION LEAD PLACEMENT UTILISING CT/MRI FUSION, MICROELECTRODE RECORDING AND TEST STIMULATION" ACTA NEUROCHIRURGICA SUPPLEMENT; 2006/99/49-50.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: COYNE ET AL. "RAPID SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION LEAD PLACEMENT UTILISING CT/MRI FUSION, MICROELECTRODE RECORDING AND TEST STIMULATION" ACTA NEUROCHIRURGICA SUPPLEMENT; 2006/99/49-50. THE ARTICLE DESCRIBES THE RESULTS FROM A STUDY THAT INVOLVED A SERIES OF 58 PATIENTS TREATED WITH BILATERAL DEEP BRAIN STIMULATION (DBS) OF THE SUBTHALAMIC NUCLEUS (STN) FOR MANAGEMENT OF SYMPTOMS RELATED TO PARKINSONS DISEASE. THE STUDY OBJECTIVE WAS TO ASSESS PATIENT SYMPTOMS PRE AND POST-OPERATIVELY. THE ARTICLE INCLUDED A NUMBER OF COMPLICATIONS RELATED TO DEEP BRAIN STIMULATION THERAPY. REPORTABLE EVENTS: FIVE LEADS (3387) WERE NOT IDEALLY PLACED AND WERE REVISED. NO INFORMATION CONCERNING PATIENT SYMPTOMS AND PATIENT OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION 3387 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Hospitalization| R DBS LEAD MODEL 3387 (N=1)| LEAD EXTENSIONS (N=2)| IPG MODEL 7426 (N=2)