BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1002325 · Received February 22, 2008

    Report

    Report Number
    2182207-2008-00879
    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 PATIENTS 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. ONE PT EXPERIENCED A SEIZURE POST DBS SURGERY AND ALSO HAD TRANSIENT LUNG EDEMA. NO TREATMENT OR OUTCOME INFO WAS 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 Other UNSPECIFIED| BILATERAL SYSTEMS WERE USED IN THE STUDY