BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 963703 · Received December 12, 2007

    Report

    Report Number
    2182207-2007-04360
    Event Type
    Injury
    Date Received
    December 12, 2007
    Report Date
    October 17, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE LIMITATIONS OF THE DATA, THE REPORTABLE EVENTS ARE BEING SUBMITTED BY COMPLICATION TYPE. THE EXACT RELATIONSHIP BETWEEN EACH PATIENT, THE DEVICES USED AND THE COMPLICATIONS EXPERIENCED WAS NOT PROVIDED. IT IS POSSIBLE THAT EACH PATIENT MAY HAVE EXPERIENCED MORE THAN ONE COMPLICATION. 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. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: VERGANI, ET AL. "ANATOMICAL IDENTIFICATION OF ACTIVE CONTACTS IN SUBTHALAMIC DEEP BRAIN STIMULATION." SURGICAL NEUROLOGY, 2007, 67:140-147. THE ARTICLE DESCRIBES THE RESULTS FROM A STUDY THAT INVOLVED PATIENTS BEING TREATED WITH BILATERAL DEEP BRAIN STIMULATION (DBS) FOR MANAGEMENT OF SYMPTOMS RELATED TO IDIOPATHIC PARKINSONS DISEASE. THE STUDY OBJECTIVE WAS TO BETTER UNDERSTAND THE MECHANISM OF ACTION RELATIONSHIP BETWEEN THE DBS ELECTRODE POSITION AND ANATOMICAL STRUCTURES OF THE SUBTHALAMIC REGION. PATIENT FOLLOW-UP WAS PERFORMED EVERY 6, 12, 24 AND 36 MONTHS POST DBS SYSTEM PLACEMENT. A NUMBER OF PATIENT COMPLICATIONS AND/OR SIDE EFFECTS WERE NOTED DURING THE STUDY. REPORTABLE EVENT(S): TWO PATIENTS (LEAD MODEL 3389 N=2) EXPERIENCED SEVERE HYPOPHONIA/DYSARTHRIA THAT WAS STIMULATOR DEPENDENT. 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 UNK YR Other LEAD EXTENSIONS (N=2)| LEAD MODEL 3389 (N=1)| KINETRA MODEL 7428 (N=1)