BEUDAMED
    FDA Adverse Event Death Summary report: N

    ITREL II

    MDR report key: 5482319 · Received March 5, 2016

    Report

    Report Number
    3007566237-2016-01288
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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. PLEASE NOTE THAT THIS DATE OF DEATH IS BASED OFF THE PUBLICATION DATE OF THE ARTICLE AS THE ACTUAL DATE OF DEATH WAS NOT PROVIDED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS IN THE ARTICLE ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: 7424, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    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¿S 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 EVENTS: 1 PATIENT DEVELOPED AN INTRACEREBRAL HEMORRHAGE (ICH) DURING SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) SURGERY AND REMAINED BEDRIDDEN. THE PATIENT DIED THREE YEARS LATER. 1 PATIENT WITH STN DBS FOR PD EXPERIENCED AN INTRACEREBRAL HEMORRHAGE WITH PERMANENT EFFECTS RELATED TO THE PROCEDURE WITHIN THE FIRST THREE POSTOPERATIVE MONTHS. 1 PATIENT WITH STN DBS FOR PD EXPERIENCED SKIN EROSION WITH INFECTION RELATED TO THE DEVICE WITHIN THE FIRST THREE POSTOPERATIVE MONTHS. THE PATIENT REQUIRED TEMPORARY REMOVAL OF THE SUBCUTANEOUS EXTENSION LEAD AND PULSE GENERATOR. THE EVENT WAS NOTED TO BE TRANSIENT. 2 PATIENTS WITH STN DBS FOR PD REQUIRED STIMULATOR REPOSITIONING RELATED TO THE DEVICE WITHIN THE FIRST THREE POSTOPERATIVE MONTHS. THIS EVENT WAS NOTED TO BE TRANSIENT. 2 PATIENTS WITH STN DBS FOR PD EXPERIENCED PERMANENT DEMENTIA RELATED TO THE PROCEDURE WITHIN THE FIRST THREE POSTOPERATIVE MONTHS. 3 PATIENTS WITH STN DBS FOR PD EXPERIENCED TRANSIENT TREATMENT-RELATED SUICIDE ATTEMPTS BETWEEN 3 MONTHS AND 5 YEARS POSTOPERATIVELY. 2 PATIENTS WITH STN DBS FOR PD EXPERIENCED TRANSIENT TREATMENT-RELATED HALLUCINATIONS BETWEEN 3 MONTHS AND 5 YEARS POSTOPERATIVELY. 3 PATIENTS WITH STN DBS FOR PD EXPERIENCED PERMANENT TREATMENT-RELATED HALLUCINATIONS BETWEEN 3 MONTHS AND 5 YEARS POSTOPERATIVELY. IT WAS NOTED THAT THESE PATIENTS HAD A PARALLEL COGNITIVE DECLINE. 1 PATIENT WITH STN DBS FOR PD EXPERIENCED TRANSIENT TREATMENT-RELATED PSYCHOSIS BETWEEN 3 MONTHS AND 5 YEARS POSTOPERATIVELY. NON-COMPLAINT W/ MED REVIEW: 3 PATIENTS WITH STN DBS FOR PD EXPERIENCED PERMANENT TREATMENT OR DISEASE-RELATED DEMENTIA BETWEEN THE THIRD AND FIFTH YEAR POSTOPERATIVELY. THE AUTHOR NOTED THAT BECAUSE THERE ARE NO CLINICALLY RELEVANT EFFECTS OF STIMULATION ON COGNITION, THESE CASES OF COGNITIVE DETERIORATION PROBABLY REFLECTED THE NATURAL HISTORY OF LONG-STANDING PD. 12 PATIENTS WITH STN DBS FOR PD EXPERIENCED TRANSIENT DELIRIUM RELATED TO THE PROCEDURE WITHIN THE FIRST THREE POSTOPERATIVE MONTHS. THIS RANGED FROM TEMPOROSPATIAL DISORIENTATION TO PSYCHOSIS AND OCCURRED DURING THE FIRST FEW DAYS AFTER SURGERY. 2 PATIENTS WITH STN DBS FOR PD EXPERIENCED TRANSIENT SEIZURES RELATED TO THE PROCEDURE WITHIN THE FIRST THREE POSTOPERATIVE MONTHS. 1 PATIENT WITH STN DBS FOR PD HAD STIMULATOR REPOSITIONING RELATED TO THE DEVICE BETWEEN 3 MONTHS AND FIVE YEARS POSTOPERATIVELY. THIS EVENT WAS NOTED TO BE TRANSIENT. 1 PATIENT WITH STN DBS FOR PD EXPERIENCED HEAD TRAUMA (FALL IN HOSPITAL) RELATED TO THE PROCEDURE WITH PERMANENT EFFECTS WITHIN THE FIRST THREE POSTOPERATIVE MONTHS. 4 PATIENTS WITH STN DBS FOR PD EXPERIENCED PERMANENT DISABLING DYSKINESIA RELATED TO THE TREATMENT WITHIN THE FIRST THREE POSTOPERATIVE MONTHS. DISABLING DYSKINESIA WAS DEFINED AS A SCORE ON THE DYSKINESIA DISABILITY ITEM OF THE UNIFIED PARKINSON¿S DISEASE RATING SCALE (UPDRS) THAT WAS GREATER THAN 2, INDICATING INTERFERENCE WITH MOTOR FUNCTION. THE AUTHOR NOTED THAT THIS WAS RELATED TO DOPAMINERGIC TREATMENT, STN STIMULATION, OR BOTH. 2 PATIENTS WITH STN DBS FOR PD EXPERIENCED PERMANENT DISABLING DYSKINESIA RELATED TO STIMULATION BETWEEN 3 MONTHS AND 5 YEARS POSTOPERATIVELY. DISABLING DYSKINESIA WAS DEFINED AS A SCORE ON THE DYSKINESIA DISABILITY ITEM OF THE UNIFIED PARKINSON¿S DISEASE RATING SCALE (UPDRS) THAT WAS GREATER THAN 2, INDICATING INTERFERENCE WITH MOTOR FUNCTION. THE AUTHOR NOTED THAT THIS WAS RELATED TO DOP AMINERGIC TREATMENT, STN STIMULATION, OR BOTH. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: LEAD MODEL 3387 OR 3389, AND IMPLANTABLE NEUROSTIMULATOR ITREL II 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
    138671 ITREL II STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7424

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Death| L| O| R| S