BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 963701 · Received December 12, 2007

    Report

    Report Number
    2182207-2007-04358
    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
    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: 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 A SERIES OF 25 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): ONE PATIENT EXPERIENCED AND INFECTION THAT REQUIRED STIMULATOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC NEUROMODULATION 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Hospitalization| R LEAD MODEL 3389 (N=2)| LEAD EXTENSIONS (N=2)