BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 991659 · Received February 5, 2008

    Report

    Report Number
    2182207-2008-00536
    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 Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL REFERENCE: AYBEK, ET AL. "LONG -TERM COGNITIVE PROFILE AND INCIDENCE OF DEMENTIA AFTER STN-DBS IN PARKINSONS DISEASE." MOV DISORD. 2007; 22(7): 974-981.

    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 DISCORD. 2007; 22 (7): 974-981. THE ARTICLE DESCRIBED 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: FIVE (5) PTS WITH BILATERAL STN-DBS FULFILLED DEMENTIA CRITERIA WHEN EXAMINED BY THE NEUROLOGIST 6 MONTHS POST-SURGERY. THESE PTS WORSENED IN ALMOST ALL COGNITIVE DOMAINS, SIGNIFICANTLY FOR THE GLOBAL MEMORY SCORE. THE 3 YEAR FOLLOW-UP REVEALED AN INCIDENCE OF DEMENTIA AFTER STN-DBS SIMILAR TO THOSE REPORTED IN MEDICALLY TREATED PTS. HOWEVER, 36% OF PTS DEVELOPING DEMENTIA DID, SO WITHIN 6 MONTHS FROM IMPLANTATION SURGERY SUGGESTING A PRECIPITATING EFFECT OF THE STIMULATION. CORRECT LEAD LOCATION WAS CONFIRMED IN ALL PTS THAT WERE CONTROLLED BY POSTOPERATIVE MRI.

    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 PULSE GENERATOR: MODEL UNK| IMPLANTABLE LEAD: MODEL UNK| IMPLANTABLE EXTENSIONS: MODEL UNK