BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1021097 · Received March 27, 2008

    Report

    Report Number
    2182207-2008-01594
    Event Type
    Injury
    Date Received
    March 27, 2008
    Report Date
    January 4, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INJOURNAL REFERENCE: RUIZ PJ, IGNESON JM, AYERBE J, ET AL. (PREDICTIVE CLINICAL FACTORS OF RESPONSE TO SUBTHALAMIC STIMULATION IN PARKINSONS DISEASE). NEUROLOGIA. 2007; 22(1): 1-4. TERNAL AUDIT.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: RUIZ PJ, IGNESON JM, AYERBE J, ET AL. (PREDICTIVE CLINICAL FACTORS OF RESPONSE TO SUBTHALAMIC STIMULATION IN PARKINSONS DISEASE). NEUROLOGIA. 2007; 22(1): 1-4. THE ARTICLE DESCRIBES A STUDY INVOLVING 20 PT IMPLANTED WITH BILATERAL (15) AND UNILATERAL (5) DEEP BRAIN STIMULATION (DBS) OF THE SUBTHALAMIC NUCLEUS FOR SYMPTOMS RELATED TO PARKINSONS DISEASE. THE PURPOSE OF THE STUDY WAS TO PROSPECTIVELY EVAL THE FACTORS THAT MAY AFFECT CLINICAL IMPROVEMENT AFTER SURGERY. ONE PT EXPERIENCED A FRONTAL HEMORRHAGE DURING SURGERY AND RECOVERED WITH MODERATE BEHAVIORAL SEQUELAE. NO ADD'L OUTCOME INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other DBS LEAD UNK (N=1)| MICROELECTRODE| LEAD IF BILATERAL SYS (N=1)