BEUDAMED
    FDA Adverse Event Summary report: N

    DEEP BRAIN STIMULATION DEVICES

    MDR report key: 921644 · Received September 21, 2007

    Report

    Report Number
    2182207-2007-03009
    Date Received
    September 21, 2007
    Report Date
    May 14, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: W.M.M. SCHUPBACH, ET AL. "STIMULATION OF THE SUBTHALAMIC NUCLEUS IN PARKINSON'S DISEASE: A 5 YEAR FOLLOW UP." J. NEUTROL. NEUROSURG. PSYCHIATRY 2005; 76: 1640-1644. THE ARTICLE DISCUSSES THE LONG TERM BENEFITS OF BILATERAL STIMULATION OF THE SUBTHALAMIC NUCLEUS (STN) IN PTS WITH ADVANCED LEVODOPA RESPONSIVE PARKINSONS DISEASE (PD). THE STUDY ASSESSED 37 PTS WITH PD TREATED WITH BILATERAL STN STIMULATION FOR FIVE YEARS. THE PTS WERE IMPLANTED WITH MODEL 3389 LEAD BILATERALLY AND MODEL 7424 NEUROSTIMULATOR. REPORTABLE EVENTS: TRANSIENT ADVERSE EVENTS OBSERVED DURING THE PERI-OPERATIVE PERIOD INCLUDED. THE 3389 LEAD (N=6) - THREE PTS EXPERIENCED A HYPOMANIC STATE. THE 3389 LEAD (N=12) - SIX PTS EXPERIENCED CONFUSION. THE 3389 LEAD (N=2) - ONE PT HAD EMOTIONAL LABILITY FOR A FEW DAYS. THE 7424 INS (N=4), 3389 LEAD (N=4) - TWO PTS EXPERIENCED TRANSIENT URINARY RETENTION REQUIRING TRANSURETHRAL RESECTION OF THE PROSTRATE. THE 3389 LEAD (N=1) - ONE PT HAD ACCIDENTAL LEAD DISCONNECT REQUIRING RE-IMPLANT. THE 7424 INS (N=3) - THREE PTS HAD INFECTION OF LEFT NEUROSTIMULATOR RESULTING IN EXPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR