BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 986257 · Received January 28, 2008

    Report

    Report Number
    2182207-2008-00426
    Event Type
    Death
    Date Received
    January 28, 2008
    Report Date
    January 4, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    JOURNAL REFERENCE: SCHUPBACH M. WELTER ML, BONNET AM, ET AL. MORTALITY IN PATIENTS WITH PARKINSONS DISEASE TREATED BY STIMULATION OF THE SUBTHALAMIC NUCLEUS. MOV DISORD. 2006; 22(2):257-261. THE ARTICLE DESCRIBES THE RESULTS OF A STUDY INVOLVING 171 PATIENTS BEING TREATED WITH BILATERAL DEEP BRAIN STIMULATION (DBS) FOR SYMPTOMS RELATED TO ADVANCED PARKINSONS DISEASE. THE GOAL OF THE STUDY WAS TO ASSESS MORTALITY AND CAUSES OF DEATH. STUDY PATIENTS WERE EVALUATED UNTIL DEATH OR JULY 2005. FOREIGN MORTALITY RATES AND UNITED STATES HISTORICAL COMPARISONS WERE USED. SIXTEEN PATIENTS DIED DURING THE STUDY PERIOD. EIGHT DEATHS WERE CLASSIFIED AS UNRELATED TO DBS TREATMENT. TWO WERE THOUGHT TO HAVE SOME RELATIONSHIP TO DBS TREATMENT AND THE SIX REMAINING COULD NOT RULE OUT THE POSSIBILITY OF SOME RELATIONSHIP TO DBS THERAPY. A FEMALE PT EXPERIENCED MAJOR DEPRESSION AND COMMITTED SUICIDE BY HANGING. IT WAS HYPOTHESIZED THAT THE POSTOPERATIVE DEPRESSION WAS CAUSED BY COMPLETE WITHDRAWAL OF L-DOPA. IN ADDITION, IT CANNOT BE EXCLUDED, THAT STN STIMULATION WAS DIRECTLY INVOLVED IN THE DECOMPENSATION OF PRE-EXISTING PSYCHIATRIC DISORDERED. THE PT EXPERIENCED MAJOR DEPRESSION AS A YOUTH AND SUFFERED ONE RELAPSE BEFORE SURGERY.

    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 57 YR Death LEAD EXTENSION (N=2)| IPG DUAL OUTPUT (1)| DBS LEAD UNK (N=1)| IPG SINGLE OUTPUT (N=2)