BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5031600 · Received August 26, 2015

    Report

    Report Number
    3007566237-2015-02389
    Event Type
    Death
    Date Received
    August 26, 2015
    Date of Event
    January 1, 2015
    Report Date
    July 28, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. PRODUCT ID NEU_ UNKNOWN_LEAD, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THE DATE OF DEATH REFLECTS THE DATE THE ARTICLE WAS RECEIVED BY THE JOURNAL FOR PUBLISHING, AS THE DATE OF DEATH WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. (B)(4).

    Description of Event or Problem · 1

    MEONI, S., ZUROWSKI, M., LOZANO, A.M., HODAIE, M., POON, Y.Y., FALLIS, M., VOON, V., MORO, E. LONG-TERM NEUROPSYCHIATRIC OUTCOMES AFTER PALLIDAL STIMULATION IN PRIMARY AND SECONDARY DYSTONIA. NEUROLOGY. 2015. 85:1-8 SUMMARY: TO EVALUATE CHANGES IN THE DIAGNOSIS OF AXIS I PSYCHIATRIC DISORDERS IN PATIENTS WITH PRIMARY AND SECONDARY DYSTONIA AFTER DEEP BRAIN STIMULATION (DBS) OF THE GLOBUS PALLIDUS INTERNUS (GPI). STRUCTURED CLINICAL INTERVIEWS FOR THE DSM-IV, AXIS I PSYCHIATRIC DISORDERS, WERE PROSPECTIVELY PERFORMED BEFORE AND AFTER SURGERY. DIAGNOSES WERE MADE BASED ON DSM-IV CRITERIA. PSYCHIATRIC DISORDERS WERE GROUPED INTO 5 CATEGORIES: MOOD, ANXIETY, ADDICTION, OBSESSIVE COMPULSIVE DISORDERS, AND PSYCHOSIS. PATIENTS COULD BE STRATIFIED TO MORE THAN ONE CATEGORY. RATES FOR UNCHANGED DIAGNOSES, DIAGNOSES IN REMISSION, AND NEW-ONSET DIAGNOSES AFTER SURGERY FOR EACH CATEGORY WERE CALCULATED. FIFTY-SEVEN PATIENTS WITH PRIMARY AND SECONDARY DYSTONIA WERE INCLUDED. MEAN 6 SD AGE AT SURGERY AND DYSTONIA DURATION AT TIME OF SURGERY WAS 50.6 6 13.8 AND 19.0 6 13.2 YEARS, RESPECTIVELY. PREOPERATIVELY, 37 AXIS I DIAGNOSES WERE MADE IN 25 PATIENTS, 43.8% OF THOSE PRESENTING WITH AT LEAST 1 AXIS I DIAGNOSIS (MOSTLY MOOD AND ANXIETY DISORDERS). MEAN 6 SD DURATION OF PSYCHIATRIC FOLLOW-UP WAS 24.4 6 19.6 MONTHS. OVERALL, AFTER SURGERY NO SIGNIFICANT CHANGES (P 5 0.16) WERE FOUND IN AXIS I DIAGNOSES (23 PATIENTS, 40.3%): 27 (73%) UNCHANGED, 10 (27%) IN COMPLETE REMISSION, AND 4 (12.9%) NEW-ONSET DIAGNOSES. OUR RESULTS SUPPORT THE OVERALL PSYCHIATRIC STABILITY OF PATIENTS WITH PRIMARY AND SECONDARY DYSTONIA TREATED WITH GPI DBS. HOWEVER, CONSIDERING THE HIGH PSYCHIATRIC MORBIDITY IN THE DYSTONIA POPULATION, PSYCHIATRIC ASSESSMENTS BEFORE AND AFTER SURGERY ARE STRONGLY RECOMMENDED. THIS STUDY PROVIDES CLASS IV EVIDENCE THAT GPI DBS DOES NOT CHANGE AXIS I PSYCHIATRIC DIAGNOSES IN PATIENTS WITH PRIMARY AND SECONDARY DYSTONIA. REPORTED EVENT: ONE SECONDARY DYSTONIA PATIENT WHO HAD RECEIVED BILATERAL GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) WAS REPORTEDLY "SUICIDAL." THE PATIENT WAS NOTED TO HAVE BEEN ADMINISTERED AN ANTIDEPRESSANT THERAPY DUE TO THE ONSET OF A "MAJOR DEPRESSIVE EPISODE" THAT HAD OCCURRED AFTER IMPLANT. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    MEONI, S., ZUROWSKI, M., LOZANO, A.M., HODAIE, M., POON, Y.Y., FALLIS, M., VOON, V., MORO, E. LONG-TERM NEUROPSYCHIATRIC OUTCOMES AFTER PALLIDAL STIMULATION IN PRIMARY AND SECONDARY DYSTONIA. NEUROLOGY. 2015. 85:1-8 SUMMARY: TO EVALUATE CHANGES IN THE DIAGNOSIS OF AXIS I PSYCHIATRIC DISORDERS IN PATIENTS WITH PRIMARY AND SECONDARY DYSTONIA AFTER DEEP BRAIN STIMULATION (DBS) OF THE GLOBUS PALLIDUS INTERNUS (GPI). STRUCTURED CLINICAL INTERVIEWS FOR THE DSM-IV, AXIS I PSYCHIATRIC DISORDERS, WERE PROSPECTIVELY PERFORMED BEFORE AND AFTER SURGERY. DIAGNOSES WERE MADE BASED ON DSM-IV CRITERIA. PSYCHIATRIC DISORDERS WERE GROUPED INTO 5 CATEGORIES: MOOD, ANXIETY, ADDICTION, OBSESSIVE COMPULSIVE DISORDERS, AND PSYCHOSIS. PATIENTS COULD BE STRATIFIED TO MORE THAN ONE CATEGORY. RATES FOR UNCHANGED DIAGNOSES, DIAGNOSES IN REMISSION, AND NEW-ONSET DIAGNOSES AFTER SURGERY FOR EACH CATEGORY WERE CALCULATED. FIFTY-SEVEN PATIENTS WITH PRIMARY AND SECONDARY DYSTONIA WERE INCLUDED. MEAN 6 SD AGE AT SURGERY AND DYSTONIA DURATION AT TIME OF SURGERY WAS 50.6 6 13.8 AND 19.0 6 13.2 YEARS, RESPECTIVELY. PREOPERATIVELY, 37 AXIS I DIAGNOSES WERE MADE IN 25 PATIENTS, 43.8% OF THOSE PRESENTING WITH AT LEAST 1 AXIS I DIAGNOSIS (MOSTLY MOOD AND ANXIETY DISORDERS). MEAN 6 SD DURATION OF PSYCHIATRIC FOLLOW-UP WAS 24.4 6 19.6 MONTHS. OVERALL, AFTER SURGERY NO SIGNIFICANT CHANGES (P 5 0.16) WERE FOUND IN AXIS I DIAGNOSES (23 PATIENTS, 40.3%): 27 (73%) UNCHANGED, 10 (27%) IN COMPLETE REMISSION, AND 4 (12.9%) NEW-ONSET DIAGNOSES. OUR RESULTS SUPPORT THE OVERALL PSYCHIATRIC STABILITY OF PATIENTS WITH PRIMARY AND SECONDARY DYSTONIA TREATED WITH GPI DBS. HOWEVER, CONSIDERING THE HIGH PSYCHIATRIC MORBIDITY IN THE DYSTONIA POPULATION, PSYCHIATRIC ASSESSMENTS BEFORE AND AFTER SURGERY ARE STRONGLY RECOMMENDED. THIS STUDY PROVIDES CLASS IV EVIDENCE THAT GPI DBS DOES NOT CHANGE AXIS I PSYCHIATRIC DIAGNOSES IN PATIENTS WITH PRIMARY AND SECONDARY DYSTONIA. REPORTED EVENT: EVENT 2. ONE FEMALE DYSTONIA PATIENT WHO HAD RECEIVED BILATERAL GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) DIED "AFTER TRAUMATIC BRAIN INJURY." THERE WAS NO FURTHER INFORMATION PROVIDED REGARDING THE PATIENT'S DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563612 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O