BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3123917 · Received May 22, 2013

    Report

    Report Number
    3007566237-2013-01702
    Event Type
    Death
    Date Received
    May 22, 2013
    Date of Event
    April 16, 2012
    Report Date
    May 10, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DATE WAS NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    URASAKI, E., FUKUDOME, T., HIROSE, M., NAKANE, S., MATSUO, H., YAMAKAWA, Y. NEUROLEPTIC MALIGNANT SYNDROME (PARKINSONISM-HYPERPYREXIA SYNDROME) AFTER DEEP BRAIN STIMULATION OF THE SUBTHALAMIC NUCLEUS. JOURNAL OF CLINICAL NEUROSCIENCE : OFFICIAL JOURNAL OF THE NEUROSURGICAL SOCIETY OF AUSTRALASIA. 2013;20(5):740-741. SUMMARY: NEUROLEPTIC MALIGNANT SYNDROME (NMS), ALSO CALLED PARKINSONISM¿HYPERPYREXIA SYNDROME (PHS), IS A SEVERE, GENERAL, SOMETIMES FATAL, PHYSICAL REACTION, INDUCED BY SUDDEN AND STRONG BLOCKADE OF DOPAMINE RECEPTORS. WHEN SUBTHALAMIC NUCLEUS (STN)¿DEEP BRAIN STIMULATION (DBS) IS USED ON PATIENTS WITH PARKINSON DISEASE (PD), DOPAMINERGIC MEDICATIONS ARE TRANSIENTLY STOPPED PRIOR TO THE PROCEDURE, AND A REDUCTION IN THE USE OF DRUGS IS ROUTINELY ATTEMPTED AFTER THE PROCEDURE. ALTHOUGH A SUDDEN STOP OR ABRUPT REDUCTION OF DOPAMINERGIC MEDICATIONS MAY SET THE STAGE FOR NMS/PHS, ONLY THREE CASES HAVE BEEN REPORTED AFTER STN¿DBS SURGERY. HERE, WE DESCRIBE A 75-YEAR-OLD WOMAN WITH PD WHO EXPERIENCED DELAYED ONSET, YET FATAL, PHSAFTER STN¿DBS. ALTHOUGH STN¿DBS MIGHT PREVENT OR SUPPRESS PHS, ITS PROTECTIVE EFFECT IS NOT ALWAYS COMPLETE. WE MUST BE AWARE THAT FATAL PHS CAN OCCUR WHEN THE USE OF MEDICATION FOR PD IS REDUCED OR ALTERED, EVEN WHEN PATIENTS ARE UNDER CONTINUOUS STN STIMULATION. REPORTED EVENT: A 75-YEAR-OLD WOMAN WITH PARKINSON¿S DISEASE WHO EXPERIENCED DELAYED ONSET, YET FATAL, PARKINSONISM-HYPERPYREXIA SYNDROME (PHS) AFTER DEEP BRAIN STIMULATION (DBS) SURGERY. WHEN THE DBS SYSTEM WAS ACTIVATED, SEVERE DYSKINESIA APPEARED IN THE PATIENT¿S EXTREMITIES. FROM DAYS 15 TO 23, DYSKINESIA HAD ALMOST SUBSIDED, ALTHOUGH DBS STIMULATION WAS CONTINUED. ON DAY 24, SEVERE TREMOR, DIAPHORESIS, AND ELEVATED BODY TEMPERATURE WERE PRESENT, AND THE PATIENT NEEDED HELP TO EAT FOOD. ON DAY 27, BODY TEMPERATURE INCREASED AND BLOOD PRESSURE FLUCTUATED FROM 140/80 TO 200/90 MMHG. HER CREATINE KINASE (CK) LEVEL WAS ELEVATED. A DIAGNOSIS OF PHS WAS MADE, AND INTRAVENOUS FLUID AND ORAL LEVODOPA/BENSERAZIDE WAS ADMINISTERED. FROM DAYS 28 TO 29, THE FEVER DECREASED, AND THE BLOOD PRESSURE NORMALIZED. THERE WERE MILD TREMORS BUT NO DYSKINESIA WAS PRESENT. ALTHOUGH DBS, FLUID TRANSFUSION, AND MEDICATION WERE MAINTAINED, AGITATION, VISUAL HALLUCINATIONS, SEVERE TREMOR, AND BRADYKINESIA APPEARED AGAIN ON DAY 31. BODY TEMPERATURE ELEVATED. EARLY IN THE MORNING OF DAY 33, THE PATIENT SUFFERED A CARDIAC ARREST AND COULD NOT BE RESUSCITATED . BLOOD EXAMINATION SHOWED HIGH CK VALUES AND POSITIVE CARDIAC TROPONIN, INDICATING PROGRESSION OF PHS ACCOMPANIED BY MYOCARDIAL INFARCTION. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226064 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Death