BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 991657 · Received February 5, 2008

    Report

    Report Number
    2182207-2008-00537
    Event Type
    Injury
    Date Received
    February 5, 2008
    Report Date
    January 15, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: AYBEK ET AL. "LONG-TERM COGNITIVE PROFILE AND INCIDENCE OF DEMENTIA AFTER STN-DBS IN PARKINSON'S DISEASE." MOV DISORD. 2007; 22(7):974-981. THE ARTICLE DESCRIBES A STUDY TO EVALUATE LONG-TERM COGNITIVE PROFILE AND INCIDENCE OF DEMENTIA IN 57 SUBJECTS WITH BILATERAL SUBTHALAMIC NUCLEUS DBS FOR PARKINSON'S DISEASE. REPORTABLE EVENT: FOUR PTS WITH BILATERAL STN-DBS HAD A TRANSIENT COMPLICATION OF CONFUSION WITH NO FURTHER INFO BEING REPORTED ON THIS EVENT.

    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 IMPLANTABLE EXTENSION MODEL UNK| IMPLANTABLE LEAD MODEL UNK| IMPLANTABLE PULSE GENERATOR MODEL UNK