BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1002329 · Received February 22, 2008

    Report

    Report Number
    2182207-2008-00875
    Event Type
    Injury
    Date Received
    February 22, 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
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: VOGES, J., R. HIKER, ET AL. (2007). "THIRTY DAYS COMPLICATION RATE FOLLOWING SURGERY PERFORMED FOR DEEP BRAIN STIMULATION." MOVEMENT DISORDERS 22(10): 1486-1489. THE ARTICLE DESCRIBES A RETROSPECTIVE STUDY OF 1,183 PTS TREATED WITH DEEP BRAIN-STIMULATION FOR A NUMBER OF CONDITIONS. DATA WAS COLLECTED FROM FIVE CENTERS. THE GOAL OF THE STUDY WAS TO EVALUATE SERIOUS ADVERSE EVENTS OCCURRING DURING THE FIRST 30 POSTOPERATIVE DAYS. A NUMBER OF PT COMPLICATIONS WERE PRESENTED IN THE ARTICLE. TWO PTS EXPERIENCED FALLS RESULTING IN BONE FRACTURES POST DBS SURGERY. TREATMENT AND OUTCOME INFO WAS NOT PROVIDED.

    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 UNK YR Hospitalization UNSPECIFIED| BILATERAL SYSTEMS WERE USED IN THE STUDY.