BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3864327 · Received June 10, 2014

    Report

    Report Number
    3007566237-2014-01590
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    May 20, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 PRODUCTS: PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 3389, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    AVILES-OLMOS, I., KEFALOPOULOU, Z., TRIPOLITI, E., CANDELARIO, J., AKRAM, H., MARTINEZ-TORRES, I., JAHANSHAHI, M., FOLTYNIE, T., HARIZ, M., ZRINZO, L., LIMOUSIN, P. LONG-TERM OUTCOME OF SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION FOR PARKINSON'S DISEASE USING AN MRI-GUIDED AND MRI-VERIFIED APPROACH. JOURNAL OF NEUROLOGY, NEUROSURGERY, AND PSYCHIATRY. 2014; 0: 1-7. DOI: 10.1136/JNNP-2013-306907 SUMMARY: SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) REPRESENTS A WELL-ESTABLISHED TREATMENT FOR PATIENTS WITH ADVANCED PARKINSON¿S DISEASE (PD) INSUFFICIENTLY CONTROLLED WITH MEDICAL THERAPIES. THIS STUDY PRESENTS THE LONG- BACKGROUND SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) REPRESENTS A WELL-ESTABLISHED TREATMENT FOR PATIENTS WITH ADVANCED PARKINSON¿S DISEASE (PD) INSUFFICIENTLY CONTROLLED WITH MEDICAL THERAPIES. THIS STUDY PRESENTS THE LONG-TERM OUTCOMES OF PATIENTS WITH PD TREATED WITH STN-DBS USING AN MRI-GUIDED/MRI-VERIFIED APPROACH WITHOUT MICROELECTRODE RECORDING. A COHORT OF 41 PATIENTS WHO UNDERWENT STNDBS WERE FOLLOWED FOR A MINIMUM PERIOD OF 5 YEARS, WITH A SUBGROUP OF 12 PATIENTS BEING FOLLOWED FOR 8¿11 YEARS. MOTOR STATUS WAS EVALUATED USING PART III OF THE UNIFIED PARKINSON¿S DISEASE RATING SCALE (UPDRS-III), IN ON- AND OFF-MEDICATION/ON-STIMULATION CONDITIONS. PREOPERATIVE AND POSTOPERATIVE ASSESSMENTS FURTHER INCLUDED ACTIVITIES OF DAILY LIVING (UPDRS-II), MOTOR COMPLICATIONS (UPDRS-IV), NEUROPSYCHOLOGICAL AND SPEECH ASSESSMENTS, AS WELL AS EVALUATION OF QUALITY OF LIFE. ACTIVE CONTACTS LOCALISATION WAS CALCULATED AND COMPARED WITH CLINICAL OUTCOMES. STN-DBS SIGNIFICANTLY IMPROVED THE OFF MEDICATION UPDRS-III SCORES, COMPARED WITH BASELINE. HOWEVER, UPDRS SCORES INCREASED OVER TIME AFTER DBS. DYSKINESIAS, MOTOR FLUCTUATIONS AND DEMANDS IN DOPAMINERGIC MEDICATION REMAINED SIGNIFICANTLY REDUCED IN THE LONG TERM. CONVERSELY, UPDRS-III ON-MEDICATION SCORES DETERIORATED AT 5 AND 8 YEARS, MOSTLY DRIVEN BY AXIAL AND BRADYKINESIA SUBSCORES. QUALITY OF LIFE, AS WELL AS DEPRESSION AND ANXIETY SCORES, DID NOT SIGNIFICANTLY CHANGE AT LONG-TERM FOLLOW-UP COMPARED WITH BASELINE. IN OUR SERIES, SEVERE COGNITIVE DECLINE WAS OBSERVED IN 17.1% AND 16.7% OF THE PATIENTS AT 5 AND 8 YEARS RESPECTIVELY. OUR DATA CONFIRM THAT STN-DBS, USING AN MRI-GUIDED/MRI-VERIFIED TECHNIQUE, REMAINS AN EFFECTIVE TREATMENT FOR MOTOR ¿OFF¿ SYMPTOMS OF PD IN THE LONG TERM WITH LOW MORBIDITY. TERM OUTCOMES OF PATIENTS WITH PD TREATED WITH STN-DBS USING AN MRI-GUIDED/MRI-VERIFIED APPROACH WITHOUT MICROELECTRODE RECORDING. METHODS A COHORT OF 41 PATIENTS WHO UNDERWENT STNDBS WERE FOLLOWED FOR A MINIMUM PERIOD OF 5 YEARS, WITH A SUBGROUP OF 12 PATIENTS BEING FOLLOWED FOR 8¿11 YEARS. MOTOR STATUS WAS EVALUATED USING PART III OF THE UNIFIED PARKINSON¿S DISEASE RATING SCALE (UPDRS-III), IN ON- AND OFF-MEDICATION/ON-STIMULATION CONDITIONS. PREOPERATIVE AND POSTOPERATIVE ASSESSMENTS FURTHER INCLUDED ACTIVITIES OF DAILY LIVING (UPDRS-II), MOTOR COMPLICATIONS (UPDRS-IV), NEUROPSYCHOLOGICAL AND SPEECH ASSESSMENTS, AS WELL AS EVALUATION OF QUALITY OF LIFE. ACTIVE CONTACTS LOCALISATION WAS CALCULATED AND COMPARED WITH CLINICAL OUTCOMES. STN-DBS SIGNIFICANTLY IMPROVED THE OFF MEDICATION UPDRS-III SCORES, COMPARED WITH BASELINE. HOWEVER, UPDRS SCORES INCREASED OVER TIME AFTER DBS. DYSKINESIAS, MOTOR FLUCTUATIONS AND DEMANDS IN DOPAMINERGIC MEDICATION REMAINED SIGNIFICANTLY REDUCED IN THE LONG TERM. CONVERSELY, UPDRS-III ON-MEDICATION SCORES DETERIORATED AT 5 AND 8 YEARS, MOSTLY DRIVEN BY AXIAL AND BRADYKINESIA SUBSCORES. QUALITY OF LIFE, AS WELL AS DEPRESSION AND ANXIETY SCORES, DID NOT SIGNIFICANTLY CHANGE AT LONG-TERM FOLLOW-UP COMPARED WITH BASELINE. IN OUR SERIES, SEVERE COGNITIVE DECLINE WAS OB SERVED IN 17.1% AND 16.7% OF THE PATIENTS AT 5 AND 8 YEARS RESPECTIVELY. OUR DATA CONFIRM THAT STN-DBS, USING AN MRI-GUIDED/MRI-VERIFIED TECHNIQUE, REMAINS AN EFFECTIVE TREATMENT FOR MOTOR ¿OFF¿ SYMPTOMS OF PD IN THE LONG TERM WITH LOW MORBIDITY. REPORTED EVENTS: 1 PATIENT SUFFERED SEIZURES DURING THE 48 HOURS AFTER SURGERY, BUT DID NOT DEVELOP EPILEPSY; 1 PATIENT EXPERIENCED HYPOMANIA THAT REQUIRED HOSPITALIZATION;. 2 PATIENTS HAD THE ELECTRODES REPOSITIONED DUE TO INSUFFICIENT RESPONSE FROM THE FIRST OPERATION;. 5 PATIENTS HAD A TRANSIENT DELIRIUM/CONFUSION EPISODE DURING THE FIRST DAYS AFTER SURGERY; 1 PATIENT WAS BED BOUND FOLLOWING A STROKE THREE YEARS AFTER SURGERY. THE REPORTER STATED THAT THE CASE WAS UNRELATED TO DBS SURGERY. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: LEAD MODEL 3389 AND SOLETRA MODEL 7426 OR KINETRA MODEL 7428 IMPLANTABLE NEUROSTIMULATORS. 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
    339856 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| O| R