BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1422461 · Received July 27, 2009

    Report

    Report Number
    2182207-2009-05174
    Event Type
    Death
    Date Received
    July 27, 2009
    Date of Event
    January 1, 2009
    Report Date
    February 6, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: VAN NUENEN BK, ESSELINK RA, MUNNEKE M, SPEELMAN JD, VA LAAR T, BLOEM BR. POSTOPERATIVE GAIT DETERIORATION AFTER BILATERAL SUBTHALAMIC NUCLEUS STIMULATION IN PARKINSON'S DISEASE. MOV DISORD. 2008; 23(16): 2404-2406. SUMMARY: THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFECTS OF SUBTHALAMIC NUCLEUS (STN) STIMULATION ON GAIT RELATIVE TO GLOBAL OUTCOME IN A GROUP OF CONSECUTIVELY OPERATED PTS WHO HAD RECEIVED STN STIMULATION BETWEEN 2001 AND 2004 IN TWO MAJOR NEUROSURGICAL CENTERS. ALL PTS HAD THE CLINICAL DIAGNOSIS OF PARKINSON'S DISEASE. A QUESTIONAIRE WAS SENT TO A TOTAL CONSECUTIVE PTS. A DELAYED WORSENING OF GAIT AFTER BILATERAL STN STIMULATION WAS EXPERIENCED BY A CONSIDERABLE PROPORTION OF PTS (42% OF SUBJECTS, FOR GAIT IN THE OFF PHASE), AND THIS WAS APPARENTLY RELATIVELY SELECTIVE BECAUSE THEIR GLOBAL OUTCOME SCORES CONTINUED TO BE IMPROVED. THESE FINDINGS HIGHLIGHT THE PRESENCE OF A HITHERTO POORLY RECOGNIZED LONG-TERM COMPLICATION OF BILATERAL STN STIMULATION. EVENT: ONE PT DIED. THE CAUSE WAS UNK AT THE TIME OF THIS REPORT AND F/U HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death LEAD: MODEL UNK