BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 6940412 · Received October 11, 2017

    Report

    Report Number
    3007566237-2017-04319
    Event Type
    Injury
    Date Received
    October 11, 2017
    Date of Event
    June 5, 2017
    Report Date
    October 11, 2017
    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

    AGE/DATE OF BIRTH.. PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE AT THE TIME OF IMPLANT OF THE THREE GROUPS OF PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED WAS NOT PROVIDED. 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 THE ARTICLE WAS ACCEPTED FOR PUBLICATION 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: 3387, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. THE EVENTS INCLUDED IN THIS REPORT WERE RECEIVED VIA THE FOLLOWING LITERATURE ARTICLE: CURY RG, FRAIX V, CASTRIOTO A, PÉREZ FERNÁNDEZ MA, KRACK P, CHABARDES S, SEIGNEURET E, ALHO EJL, BENABID AL, MORO E. THALAMIC DEEP BRAIN STIMULATION FOR TREMOR IN PARKINSON DISEASE, ESSENTIAL TREMOR, AND DYSTONIA. NEUROLOGY (2017) 89:1-8 ABSTRACT: THE OBJECTIVE OF THIS STUDY WAS TO REPORT ON THE LONG-TERM OUTCOMES OF DEEP BRAIN STIMULATION (DBS) OF THE THALAMIC VENTRAL INTERMEDIATE NUCLEUS (VIM) IN PARKINSON DISEASE (PD), ESSENTIAL TREMOR (ET), AND DYSTONIC TREMOR. ONE HUNDRED FIFTY-NINE PATIENTS WITH PD, ET, AND DYSTONIA UNDERWENT VIM DBS DUE TO REFRACTORY TREMOR AT THE GRENOBLE UNIVERSITY HOSPITAL. THE PRIMARY OUTCOME WAS A CHANGE IN THE TREMOR SCORES AT 1 YEAR AFTER SURGERY AND AT THE LATEST FOLLOW-UP (21 YEARS). SECONDARY OUTCOMES INCLUDED THE RELATIONSHIP BETWEEN TREMOR SCORE REDUCTION OVER TIME AND THE ACTIVE CONTACT POSITION. TREMOR SCORES (UNIFIED PARKINSON¿S DISEASE RATING SCALE-III, ITEMS 20 AND 21; FAHN, TOLOSA, MARIN TREMOR RATING SCALE) AND THE COORDINATES OF THE ACTIVE CONTACTS WERE RECORDED. NINETY-EIGHT PATIENTS WERE INCLUDED. PATIENTS WITH PD AND ET HAD SUSTAINED IMPROVEMENT IN TREMOR WITH VIM STIMULATION (MEAN IMPROVEMENT, 70% AND 66% AT 1 YEAR; 63% AND 48% BEYOND 10 YEARS, RESPECTIVELY). THERE WAS NO SIGNIFICANT LOSS OF STIMULATION BENEFIT OVER TIME. PATIENTS WITH DYSTONIA EXHIBITED A MODERATE RESPONSE AT 1-YEAR FOLLOW-UP (41% TREMOR IMPROVEMENT), WHICH WAS NOT SUSTAINED AFTER 5 YEAR S (30% IMPROVEMENT). THE MORE DORSAL ACTIVE CONTACTS¿ COORDINATES IN THE RIGHT LEAD WERE RELATED TO A BETTER OUTCOME 1 YEAR AFTER SURGERY. DURING THE WHOLE FOLLOW-UP, FORTY-EIGHT PATIENTS (49%) EXPERIENCED MINOR SIDE EFFECTS, WHEREAS 2 (2.0%) HAD SERIOUS EVENTS (B RAIN HEMORRHAGE AND INFECTION). VIM DBS IS AN EFFECTIVE LONG-TERM (BEYOND 10 YEARS) TREATMENT FOR TREMOR IN PD AND ET. EFFECTS ON DYSTONIC TREMOR WERE MODEST AND TRANSIENT. 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: 1 PATIENT WITH THALAMIC VENTRAL INTERMEDIATE NUCLEUS (VIM) DEEP BRAIN STIMULATION (DBS) EXPERIENCED A RIGHT THALAMIC HEMORRHAGE DURING THE IMPLANT SURGERY, WITH MILD LEFT HEMIPARESIS THAT RECOVERED PARTIALLY AFTER A FEW WEEKS. ONE (1) MALE PATIENT WITH VIM DBS DEVELOPED AN INFECTION AND HAD HIS ELECTRODE REMOVED. ONE (1) PATIENT WITH VIM DBS HAD AN ELECTRODE REPLACED DUE TO MALPOSITION. 4. ONE (1) PATIENT WITH VIM DBS RECEIVED GLOBUS PALLIDUS (GPI) STIMULATION AFTER VIM DBS DUE TO INTOLERABLE SIDE EFFECTS RELATED TO STIMULATION. THREE (3) PATIENTS WITH VIM DBS RECEIVED GLOBUS PALLIDUS (GPI) STIMULATION AFTER VIM DBS DUE TO A LACK OF EFFICACY. THE FOLLOWING DEVICE SPECIFICS WERE INCLUDED IN THE ARTICLE: LEAD MODEL 3387; ITREL IMPLANTABLE NEUROSTIMULATOR; SOLETRA IMPLANTABLE NEUROSTIMULATOR; KINETRA IMPLANTABLE NEUROSTIMULATOR; ACTIVA IMPLANTABLE NEUROSTIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721110 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R