BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1324575 · Received February 20, 2009

    Report

    Report Number
    2182207-2009-01219
    Event Type
    Death
    Date Received
    February 20, 2009
    Report Date
    February 21, 2009
    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

    FONCKE, E M.J., ET AL. SUICIDE AFTER DEEP BRAIN STIMULATION OF THE INTERNAL GLOBUS PALLIDUS FOR DYSTONIA NEUROLOGY VOLUME 66(1) JANUARY 10, 2006. DEVICE MANUFACTURER NOT IDENTIFIED. ALSO SEE MANUFACTURER REPORT NUMBER 2182207-2009-01218. THE SECOND PATIENT HAD PRIMARY GENERALIZED DYSTONIA (35 YEARS DISEASE DURATION) AND NO BENEFIT FROM PHARMACOLOGIC THERAPY. HE EXPERIENCED TWO MILD DEPRESSIVE PERIODS WITHOUT SUICIDAL IDEATION, WHICH WERE PRECIPITATED BY RELATIONAL PROBLEMS. HE WAS SUCCESSFULLY TREATED WITH PAROXETINE FOR THESE EPISODES. DURING CHILDHOOD, SEVERAL PSYCHIATRIC ASSESSMENTS POINTED TO AN ANXIOUS CHILD WITH SOCIAL PHOBIAS. SIX MONTHS POSTOPERATIVELY, HE HAD AN EXCELLENT IMPROVEMENT, HE REGAINED SOCIAL LIFE, AND HE WAS FREE OF MEDICATION (PREOPERATIVELY, BOTULINUM TOXIN INJECTIONS AND ANALGETICS PROVIDED SOME RELIEF OF THE SEVERE NECK PAIN). FOURTEEN MONTHS AFTER SURGERY, HE WAS ABLE TO PERFORM HIS JOB AT THE CHILDREN'S FARM, WHICH HAD NOT BEEN POSSIBLE FOR YEARS BECAUSE OF THE SEVERITY OF THE DYSTONIA. TWO WEEKS BEFORE COMMITTING SUICIDE (AUTO-STRANGULATION AT HOME), HE WAS SEEN AT OUR DEPARTMENT AND WAS VERY HAPPY WITH THE RESULT OF THE SURGERY. ONE DAY BEFORE COMMITTING SUICIDE, HE VISITED HIS BROTHER AND WAS FULL OF ENERGY WITHOUT SINGS OF (HYPO)MANIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death LOT# UNK| LEAD: MODEL LEAD| EXPLANTED:| EXTENSION: MODEL EXTENSION| IMPLANTABLE PULSE GENERATOR: MODEL IPGNEURO| EXPLANTED:| EXPLANTED: