BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1021063 · Received March 27, 2008

    Report

    Report Number
    2182207-2008-01607
    Event Type
    Injury
    Date Received
    March 27, 2008
    Report Date
    November 25, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED FOLLOWING AN INTERNAL AUDIT. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: CARILLO RUIZ JD, ET AL. "NEUROMODULATION OF PRELEMNICAL RADIATIONS IN THE TREATMENT OF PARKINSON'S DISEASE." ACTA NEUROCHIR SUPPL 2007;97(2):185-190. THIS PUBLICATION DESCRIBES A STUDY, WHERE 20 PATIENTS WERE IMPLANTED WITH BILATERAL (N=5) AND UNILATERAL (N=15) DEEP BRAIN STIMULATION (DBS) OF THE PRELEMNIXAL RADIATIONS (RAPRL) FOR UNILATERAL PRONOUNCED TREMOR AND RIGIDITY IN PATIENTS IMPLANTED BILATERALLY OR BILATERAL SYMPTOMS INCLUDING SEVERE BRADYKINESIA IN PATIENTS IMPLANTED UNILATERALLY. THE PURPOSE OF THE STUDY WAS TO EVALUATE RAPRL NEUROMODULATION IN THE TREATMENT OF TREMOR, RIGIDITY, AND BRADYKINESIA IN PATIENTS WITH PARKINSON'S DISEASE. SOME PATIENT COMPLICATIONS WERE NOTED IN THE ARTICLE. REPORTABLE EVENT: BILATERAL IMPLANTATION OF THE ELECTRODES WAS FOLLOWED BY A TRANSIENT STATE OF SOMNOLENCE THAT LASTED FOR HOURS TO DAYS.

    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 Other PROGRAMMER MODEL UNK N=1| LEAD MODEL 3387 N=1| IMPLANTABLE EXTENSIONS MODEL UNK N=2| IMPLANTABLE NEURO STIMULATOR MODEL UNK N=1