BEUDAMED
    FDA Adverse Event Summary report: N

    DEEP BRAIN STIMULATION DEVICES

    MDR report key: 921661 · Received September 21, 2007

    Report

    Report Number
    2182207-2007-03045
    Date Received
    September 21, 2007
    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.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: BINDER, D, ET AL. "RISK FACTORS FOR HEMORRHAGE DURING MICROELECTRODE-GUIDED DEEP BRAIN STIMULATOR IMPLANTATION FOR MOVEMENT DISORDERS." NEUROSURGERY ONLINE. 2005; 56(4): 722-732. THE ARTICLE ANALYZED THE RISK FACTORS FOR SYMPTOMATIC AND ASYMPTOMATIC HEMORRHAGE IN DBS IMPLANTATIONS INTO THE SUBTHALAMIC NUCLEUS, VENTROLATERAL THALAMUS, AND INTERNAL GLOBUS PALLIDUS. REPORTABLE EVENTS: 3387 LEAD (N=1) - PT 1 EXPERIENCED AN INTRACRANIAL DURING A POST OPERATIVE COUGHING FIT. THE PATIENT DEVELOPED A PERMANENT NEUROLOGICAL DEFICIT. 3387 LEAD (N=1) - PT 2 EXPERIENCED A SYMPTOMATIC HEMORRHAGE AT THE END OF THE PROCEDURE. THE PATIENT RECOVERED. 3387 LEAD (N=1) - PATIENT 5 EXPERIENCED A SYMPTOMATIC HEMORRHAGE EVOLVING POSTOPERATIVELY. THE PATIENT RECOVERED.

    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 YR