BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK DEEP BRAIN STIMULATOR

    MDR report key: 1349725 · Received March 22, 2009

    Report

    Report Number
    2182207-2009-02024
    Event Type
    Death
    Date Received
    March 22, 2009
    Report Date
    March 27, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    LITERATURE : BURKHARD P ET AL. "SUICIDE AFTER SUCCESSFUL DEEP BRAIN STIMULATION FOR MOVEMENT DISORDERS." NEUROLOGY, 2004. 63:2170-2172. THIS ARTICLE HIGHLIGHTS 6 PTS TREATED WITH DBS THAT COMMITTED SUICIDE DURING TREATMENT. RESULTS. DURING THE 9-YEAR FOLLOW-UP PERIOD, 6 OF THE 140 DBS-TREATED PTS COMMITTED SUICIDE, CORRESPONDING TO AN OVERALL PREVALENCE OF 4.3%. CHARACTERISTICS SHARED BY MOST OF THESE SUICIDE PTS WERE AS FOLLOWS: THERE WAS A MAJORITY OF YOUNG MALES WITH PD (FOUR CASES), ET (ONE CASE), AND POSTANOXIC DYSTONIA (ONE CASE), 3 LASTING FOR 22.3 YEARS (RANGE 6 TO 52 YEARS); FOUR OF SIX PTS HAD TWO SUCCESSIVE DBS SURGERIES, THE CURRENT TARGET AND ELECTRICAL PARAMETERS OF STIMULATION BEING DIFFERENT IN EACH PT (PT 5 HAD BILATERAL GPI AND STN STIMULATION SIMULTANEOUSLY AND PT 6 WAS STIMULATED ON ONE SIDE ONLY AT THE TIME OF DEATH); ALL BUT ONE HAD A PREVIOUS HISTORY OF SEVERE DEPRESSION AND OTHER PSYCHIATRIC FEATURES, SOME WITH SUICIDE ATTEMPT OR IDEATIONS PRIOR TO DBS; DEATH BY SUICIDE OCCURRED 3.1 YRS (RANGE 4 MONTHS TO 7 YEARS) AFTER THE LAST DBS SURGERY, (SUICIDE WAS UNANNOUNCED BUT LONG PREPARED IN MOST, SOMETIMES WITH THE HELP OF AN EUTHANASIA GROUP; METHOD OF SUICIDE WAS VIOLENT IN THREE); FOUR PTS WERE TREATED WITH ANTIDEPRESSANTS OR FOLLOWED BY A PSYCHIATRIST OR BOTH AT THE TIME OF DEATH; DBS RESTORED A GOOD TO EXCELLENT MOTOR FUNCTION TO ALL PTS, THREE OF WHOM WERE RECEIVING NO MEDICATION FOR MOVEMENT DISORDERS AT THE TIME OF DEATH (NO RECENT CHANGES IN ELECTRICAL PARAMETERS OR DRUG WERE PERFORMED); NONE WAS DEMENTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death EXPLANTED:| EXTENSION: MODEL EXTENSION| LEAD: MODEL LEADMVD| EXPLANTED: