BEUDAMED
    FDA Adverse Event Summary report: N

    DEEP BRAIN STIMULATION DEVICES

    MDR report key: 921640 · Received September 21, 2007

    Report

    Report Number
    2182207-2007-03046
    Date Received
    September 21, 2007
    Report Date
    September 29, 2006
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: HENDERSON JAIMIE M, TKACH JEAN, PHILLIPS MICHAEL, ET AL. "PERMANENT NEUROLOGICAL DEFICIT RELATED TO MAGNETIC RESONANCE IMAGING IN A PT WITH IMPLANTED DEEP BRAIN STIMULATION ELECTRODE FOR PARKINSON'S DISEASE: CASE REPORT." NEUROSURGERY. NOV 2005; 57(5): E1603. REPORTABLE EVENTS: THE 3387 LEAD (N=2), EXTENSION (N=2) - THE ARTICLE DESCRIBES A CASE OF SERIOUS PERMANENT NEUROLOGICAL INJURY SECONDARY TO A RADIOFREQUENCY LESION PRODUCED BY HEATING OF A DBS ELECTRODE ASSOCIATED WITH MRI OF THE LUMBAR SPINE IN A PT WITH PARKINSON'S DISEASE. A CT SCAN IDENTIFIED A HEMORRHAGE AND EDEMA SURROUNDING THE TIP OF THE ELECTRODE. SEVEN MONTHS POST MRI INJURY, THE PT WAS NOTED TO HAVE HEMIPARESIS, DYSARTHRIA AND DYSCONJUGATE GAZE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Disability