BEUDAMED
    FDA Adverse Event Death Summary report: N

    ITREL II

    MDR report key: 5482255 · Received March 5, 2016

    Report

    Report Number
    3007566237-2016-01284
    Event Type
    Death
    Date Received
    March 5, 2016
    Date of Event
    November 13, 2003
    Report Date
    February 5, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THE ACTUAL DATE OF DEATH WAS NOT PROVIDED IN THE LITERATURE ARTICLE; THIS DATE IS BASED ON THE DATE OF ARTICLE PUBLICATION. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. (B)(4).

    Description of Event or Problem · 0

    KRACK, P., BATIR, A., BLERCOM, N. V., CHABARDES, S., FRAIX, V., ARDOUIN, C., KOUDSIE, A., LIMOUSIN, P. D., BENAZZOUZ, A., LEBAS, J. F., BENABID, A. L., POLLAK, P. FIVE-YEAR FOLLOW-UP OF BILATERAL STIMULATION OF THE SUBTHALAMIC NUCLEUS IN ADVANCED PARKINSON'S DISEASE. THE NEW ENGLAND JOURNAL OF MEDICINE. 2003; 349:1925-34. SUMMARY: ALTHOUGH THE SHORT-TERM BENEFITS OF BILATERAL STIMULATION OF THE SUBTHALAMIC NUCLEUS IN PATIENTS WITH ADVANCED PARKINSON'S DISEASE HAVE BEEN WELL DOCUMENTED, THE LONG-TERM OUTCOMES OF THE PROCEDURE ARE UNKNOWN. WE CONDUCTED A FIVE-YEAR PROSPECTIVE STUDY OF THE FIRST 49 CONSECUTIVE PATIENTS WHOM WE TREATED WITH BILATERAL STIMULATION OF THE SUBTHALAMIC NUCLEUS. PATIENTS WERE ASSESSED AT ONE, THREE, AND FIVE YEARS WITH LEVODOPA (ON MEDICATION) AND WITHOUT LEVODOPA (OFF MEDICATION), WITH USE OF THE UNIFIED PARKINSON&#38112;DISEASE RATING SCALE. SEVEN PATIENTS DID NOT COMPLETE THE STUDY: THREE DIED, AND FOUR WERE LOST TO FOLLOW-UP. AS COMPARED WITH BASE LINE, THE PATIENTS' SCORES AT FIVE YEARS FOR MOTOR FUNCTION WHILE OFF MEDICATION IMPROVED BY 54 PERCENT (P<(><<)>0.001) AND THOSE FOR ACTIVITIES OF DAILY LIVING IMPROVED BY 49 PERCENT (P<(><<)>0.001). SPEECH WAS THE ONLY MOTOR FUNCTION FOR WHICH OFF MEDICATION SCORES DID NOT IMPROVE. THE SCORES FOR MOTOR FUNCTION ON MEDICATION DID NOT IMPROVE ONE YEAR AFTER SURGERY, EXCEPT FOR THE DYSKINESIA SCORES. ON-MEDICATION AKINESIA, SPEECH, POSTURAL STABILITY, AND FREEZING OF GAIT WORSENED BETWEEN YEAR 1 AND YEAR 5 (P<(><<)>0.001 FOR ALL COMPARISONS). AT FIVE YEARS, THE DOSE OF DOPAMINERGIC TREATMENT AND THE DURATION AND SEVERITY OF LEVODOPA-INDUCED DYSKINESIA WERE REDUCED, AS COMPARED WITH BASE LINE (P<(><<)>0.001 FOR EACH COMPARISON). THE AVERAGE SCORES FOR COGNITIVE PERFORMANCE REMAINED UNCHANGED, BUT DEMENTIA DEVELOPED IN THREE PATIENTS AFTER THREE YEARS. MEAN DEPRESSION SCORES REMAINED UNCHANGED. SEVERE ADVERSE EVENTS INCLUDED A LARGE INTRACEREBRAL HEMORRHAGE IN ONE PATIENT. ONE PATIENT COMMITTED SUICIDE. PATIENTS WITH ADVANCED PARKINSON'S DISEASE WHO WERE TREATED WITH BILATERAL STIMULATION OF THE SUBTHALAMIC NUCLEUS HAD MARKED IMPROVEMENTS OVER FIVE YEARS IN MOTOR FUNCTION WHILE OFF MEDICATION AND IN DYSKINESIA WHILE ON MEDICATION. THERE WAS NO CONTROL GROUP, BUT WORSENING OF AKINESIA, SPEECH, POSTURAL STABILITY, FREEZING OF GAIT, AND COGNITIVE FUNCTION BETWEEN THE FIRST AND THE FIFTH YEAR IS CONSISTENT WITH THE NATURAL HISTORY OF PARKINSON'S DISEASE. REPORTED EVENT: [MALE] 1 PATIENT WITH STN DBS FOR PD WAS KNOWN TO BE SEVERELY DEPRESSED AND HAD SUICIDAL IDEATION THREE MONTHS BEFORE SURGERY AND COMMITTED SUICIDE SIX MONTHS AFTER SURGERY. THE AUTHOR NOTED THAT IT WAS POSSIBLE THAT THE REDUCTION IN THE DOSE OF DOPAMINERGIC MEDICATION CONTRIBUTED TO HIS SUICIDE. FOLLOW-UP TO THE ARTICLE'S CORRESPONDING AUTHOR HAS BEEN REQUESTED FOR ADDITIONAL INFORMATION, PATIENT/DEVICE INFO AND EVENT DATES. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138670 ITREL II STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7424 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    0 00055 YR Death