BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 7183418 · Received January 11, 2018

    Report

    Report Number
    3007566237-2018-00141
    Event Type
    Injury
    Date Received
    January 11, 2018
    Date of Event
    August 16, 2017
    Report Date
    January 11, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVERAGE AGE OF PATIENTS IN EACH GROUP INCLUDED IN THIS ARTICLE ARE AS FOLLOWS: 42.2 YEARS (ISOLATED IDIOPATHIC/ISOLATED INHERITED DYSTONIA); 40.3 YEARS (INHERITED DYSTONIA + OTHER NEUROLOGICAL FEATURES); 41.8 YEARS (ACQUIRED DYSTONIA) SEX. PLEASE NOTE THAT THIS IS THE GENDER OF THE MAJORITY OF PATIENTS REPORTED IN THE ARTICLE AS THE ACTUAL GENDERS OF PATIENTS INVOLVED WAS NOT PROVIDED. DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN, SERIAL# UNKNOWN, PRODUCT TYPE: UNKNOWN. THE REPORTED EVENTS WERE FROM THE FOLLOWING LITERATURE ARTICLE: MEONI S, FRAIX V, CASTRIOTO A, BENABID AL, SEIGNEURET E, VERCUEIL L, POLLACK P, KRACK P, CHEVRIER E, CHABARDES S, MORO E. PALLIDAL DEEP BRAIN STIMULATION FOR DYSTONIA: A LONG TERM STUDY. J NEUROL NEUROSURG PSYCHIATRY 2017; 88: 960-967 DOI: 10.1136/JNNP-2016-315504 ABSTRACT: PALLIDAL DEEP BRAIN STIMULATION (GLOBUS PALLIDUS INTERNUS [GPI] DBS) IS THE BEST THERAPEUTIC OPTION FOR DISABLING ISOLATED IDIOPATHIC (IID) AND INHERITED (INH) DYSTONIA. ACQUIRED DYSTONIA (AD) MAY ALSO BENEFIT FROM GPI DBS. EFFICACY AND SAFETY IN THE LONG-TERM REMAINED TO BE ESTABLISHED. THE OBJECTIVE WAS TO RETROSPECTIVELY ASSESS LONG-TERM CLINICAL OUTCOMES AND SAFETY IN DYSTONIC PATIENTS WHO UNDERWENT GPI DBS. PATIENTS WERE VIDEOTAPED AND ASSESSED PREOPERATIVELY AND POSTOPERATIVELY (1-YEAR AND AT LAST AVAILABLE FOLLOW-UP) USING THE BURKE-FAHN-MARSDEN DYSTONIA RATING SCALE (MOTOR SCORE (BFMDRS-M); DISABILITY SCORE (BFMDRS-D)). SIXTY-ONE PATIENTS WERE INCLUDED (FOLLOW-UP 7.9 ± 5.9 YEARS; RANGE 1-20.7). IN IID AND INH (N=37), THE BFMDRS-M IMPROVED AT FIRST (20.4 ± 24.5; P<(><<)>0.00001) AND LAST (22.2 ± 18.2; P<(><<)>0.001) FOLLOW-UPS COMPARED WITH PREOPERATIVELY (50.5 ± 28.0). IN AD (N=19), THE BFMDRS-M AMELIORATED AT 1-YEAR (40.8 ± 26.5; P <(><<)>0.02) AND LATE FOLLOW-UPS (44.3 ± 24.3; P<(><<)>0.04) COMPARED WITH PREOPERATIVELY (52.8 ± 24.2). IN INH DYSTONIA WITH OTHER NEUROLOGICAL FEATURES (N=4), THERE WAS NO MOTOR BENEFIT. IN IID AND INH, THE BFMDRS-D IMPROVED AT 1-YEAR (9.5 ±7.5; P<(><<)>0.0002) AND LATE FOLLOW-UPS (10.4 ± 7.8; P<(><<)>0.016) COMPARED WITH PREOPERATIVELY (13.3 ± 6.9). IN AD, THE BFMDRS-D REDUCED AT 1-YEAR (12.0 ± 8.1; P<(> <<)>0.01) AND LATE FOLLOW-UPS (12.7 ± 6.1; P=0.2) COMPARED WITH PREOPERATIVELY (14.35 ± 5.7). MOST ADVERSE EVENTS WERE HARDWARE RELATED. GPI DBS IS AN EFFECTIVE AND SAFE TREATMENT IN MOST PATIENTS WITH DYSTONIA. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE FOLLOWING EVENTS WERE REPORTED VIA LITERATURE ARTICLE: REPORTED EVENTS: FOUR (4) PATIENTS WITH GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) FOR DYSTONIA EXPERIENCED SERIOUS HARDWARE-RELATED INFECTIONS. IT WAS NOTED THAT THE BATTERY INFECTIONS SPREAD TO THE EXTENSIONS AND, IN SOME CASES, THE ELECTRODES. REPLACEMENT OF THE INFECTED COMPONENTS WAS PERFORMED IN ALL CASES WITH SUCCESS. THERE WERE NO PERMANENT NEUROLOGICAL SEQUELAE. THREE (3) PATIENTS WITH GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) FOR DYSTONIA EXPERIENCED SERIOUS HARDWARE-RELATED SCALP INFECTIONS. REPLACEMENT OF THE INFECTED COMPONENTS WAS PERFORMED IN ALL CASES WITH SUCCESS. THERE WERE NO PERMANENT NEUROLOGICAL SEQUELAE. ONE (1) PATIENT WITH GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) FOR DYSTONIA EXPERIENCED SURGERY-RELATED RESPIRATORY FAILURE SECONDARY TO ASPIRATION PNEUMONIA SIX DAYS AFTER SURGERY. THERE WERE NO PERMANENT NEUROLOGICAL SEQUELAE. TEN (10) PATIENTS WITH GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) FOR DYSTONIA EXPERIENCED LEAD OR EXTENSION BREAKAGE. REPLACEMENT OF THE BROKEN COMPONENTS WAS PERFORMED IN ALL CASES WITH SUCCESS. THERE WERE NO PERMANENT NEUROLOGICAL SEQUELAE. ONE (1) PATIENT WITH GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) FOR DYSTONIA EXPERIENCED TWO EPISODES OF BILATERAL EXTENSION FRACTURE AT THE CERVICAL LEVEL. IT WAS NOTED THAT THIS PATIENT HAD SEVERE DYSTONIC TREMOR OF THE NECK. REPLACEMENT OF THE BROKEN COMPONENT WAS PERFORMED WITH SUCCESS. THERE WERE NO PERMANENT NEUROLOGICAL SEQUELAE. THREE (3) PATIENTS WITH GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) FOR DYSTONIA EXPERIENCED IMPLANTABLE NEUROSTIMULATOR (INS) MALFUNCTION. THE MALFUNCTIONING INS¿S WERE REPLACED IN ALL CASES WITH SUCCESS. THERE WERE NO PERMANENT NEUROLOGICAL SEQUELAE. ONE (1) PATIENT HAD SUPPLEMENTAL BILATERAL SUBTHALAMIC NUCLEUS (STN) DBS AFTER GPI DBS PERFORMED TWICE DUE TO LOSS OF BENEFIT FROM PALLIDAL STIMULATION. TWO (2) PATIENTS WITH GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) FOR DYSTONIA EXPERIENCED SURGERY-RELATED SMALL SUBDURAL HEMATOMAS FOLLOWING STEREOTAXIC FRAME FIXATION. THIS DID NOT REQUIRE SURGICAL EVACUATION. THERE WERE NO PERMANENT NEUROLOGICAL SEQUELAE. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: LEAD MODEL 3387; LEAD MODEL 3389; IMPLANTABLE NEUROSTIMULATOR ITREL II; IMPLANTABLE NEUROSTIMULATOR KINETRA; IMPLANTABLE NEUROSTIMULATOR ACTIVA PC, IMPLANTABLE NEUROSTIMULATOR ACTIVA RC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27565 IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R