BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 977468 · Received January 10, 2008

    Report

    Report Number
    2182207-2008-00115
    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 Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: LINAZASORO ET AL. "THREE IN ONE: CASE REPORT SUPPORTING DIFFERENT ORIGINS OF ESSENTIAL AND PARKINSONIAN TREMORS" EUR NEUROL: 2006/55/2/108-9. THE ARTICLE IS A CASE REPORT OF A FEMALE WHO PRESENTED WITH TREMORS OF DIVERSE ETIOLOGY, SHOWING DIFFERENT RESPONSES TO DIFFERENT THERAPEUTIC APPROACHES. BASED ON A DIAGNOSIS OF SEVERE ET (ESSENTIAL TREMOR), A BILATERAL DEEP BRAIN STIMULATION OF THE VIM THALAMIC NUCLEUS WAS INDICATED AS ONE OF THE TREATMENTS. DESPITE IMPROVEMENT OF THE TREMORS, THE STIMULATION ALSO INDUCED DYSARTHRIA IN THE PATIENT.

    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 66 YR Other IMPLANTABLE STIMULATOR| EXTENSIONS