BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

    MDR report key: 5966872 · Received September 21, 2016

    Report

    Report Number
    3007566237-2016-03330
    Event Type
    Injury
    Date Received
    September 21, 2016
    Date of Event
    May 22, 2016
    Report Date
    September 21, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT AGE: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PT SEX: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. NOTE, THE SECOND ARTICLE CITED, WHICH CONTAINED THE EVENT INFORMATION THAT MADE THE FILE REPORTABLE, WAS RECEIVED ON 2016-09-01, AFTER THE INITIAL ARTICLE, WHICH ITSELF DID NOT CONTAIN REPORTABLE INFORMATION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    KOY, A., TIMMERMANN, L. DEEP BRAIN STIMULATION IN CEREBRAL PALSY: CHALLENGES AND OPPORTUNITIES. EUROPEAN JOURNAL OF PAEDIATRIC NEUROLOGY : EJPN : OFFICIAL JOURNAL OF THE EUROPEAN PAEDIATRIC NEUROLOGY SOCIETY. 2016. 1090. (1-4). DOI: 10.1016/J.EJPN.2016.05.015. SUMMARY: CEREBRAL PALSY (CP) IS THE MOST COMMON CAUSE FOR ACQUIRED DYSTONIA IN CHILDHOOD. PHARMACOLOGICAL TREATMENT IS OFTEN UNSATISFACTORY AND SIDE EFFECTS ARE FREQUENTLY DOSE-LIMITING. DATA ON OUTCOME OF DBS IN PAEDIATRIC PATIENTS WITH DYSKINETIC CP IS VERY LIMITED AND HETEROGENEOUS. REASONS FOR THE VARIABILITY IN RESPONSES ARE NOT ENTIRELY KNOWN YET. INTERESTINGLY, SOME CP-PATIENTS SEEM TO IMPROVE SUBJECTIVELY ON PALLIDAL STIMULATION BUT WITHOUT MEASURABLE CHANGES IN IMPAIRMENT SCALES. BESIDES DYSTONIA SCALES, THE USE OF SENSITIVE AGE-DEPENDENT ASSESSMENTS TOOLS IS THEREFORE REASONABLE TO CAPTURE THE FULL EFFECT. AS THE COURSE OF DISEASE DURATION AS WELL AS THE AGE AT OPERATION SEEM TO CORRELATE WITH DBS OUTCOME IN PATIENTS WITH DYSTONIA, DBS AT AN EARLY STAGE OF DEVELOPMENT MIGHT BE BENEFICIAL FOR SOME OF THESE PATIENTS. FOR THE FUTURE, WELL-CONDUCTED TRIALS AS WELL AS DATA COLLECTION IN THE INTERNATIONAL REGISTRY IS OF MAJOR IMPORTANCE TO INCREASE KNOWLEDGE ABOUT DBS IN CP PATIENTS, ESPECIALLY THOSE IMPLANTED AT A YOUNG AGE. FURTHERMORE, SELECTION CRITERIA AND GUIDELINES OR TREATMENT STANDARDS ARE NEEDED TO IMPROVE THE SERVICE FOR CHILDREN WITH DYSKINETIC CP E ESPECIALLY IN LIGHT OF UNSATISFACTORY MEDICAL TREATMENT OPTIONS. KOY A, ET AL., GERMAN REGISTRY OF PAEDIATRIC DEEP BRAIN STIMULATION IN PATIENTS WITH CHILDHOOD-ONSET DYSTONIA (GEPESTIM), EUROPEAN JOURNAL OF PAEDIATRIC NEUROLOGY (2016), 10.1016/J.EJPN.2016.05.023. SUMMARY: BACKGROUND: DATA ON PAEDIATRIC DEEP BRAIN STIMULATION (DBS) IS LIMITED, ESPECIALLY FOR LONGTERM OUTCOMES, BECAUSE OF SMALL NUMBERS IN SINGLE CENTER SERIES AND LACK OF SYSTEMATIC MULTI-CENTER TRIALS. OBJECTIVES: WE SEEK TO SYSTEMATICALLY EVALUATE THE CLINICAL OUTCOME OF PAEDIATRIC PATIENTS UNDERGOING DBS. METHODS: A GERMAN REGISTRY ON PAEDIATRIC DBS (GEPESTIM) WAS CREATED TO COLLECT DATA OF PATIENTS WITH DYSTONIA UNDERGOING DBS UP TO THE AGE OF 18 YEARS. PATIENTS WERE DIVIDED INTO THREE GROUPS ACCORDING TO ETIOLOGY (GROUP 1 INHERITED, GROUP 2 ACQUIRED, AND GROUP 3 IDIOPATHIC DYSTONIA). REPORTED EVENTS: APPROX 2 PATIENTS WITH DEEP BRAIN STIMULATION (DBS) FOR DYSTONIA EXPERIENCED INFECTION/HEALING PROBLEMS THAT REQUIRED IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT. THE AUTHORS NOTED THAT SEVERAL DIFFERENT PATHOGENS WERE DOCUMENTED, INCLUDING: STAPHYLOCOCCUS AUREUS, STAPHYLOCOCCUS EPIDERMIDIS, AND PSEUDOMONAS AERUGINOSA. HOWEVER, IT REMAINS UNCLEAR WHICH PATHOGEN WAS FOUND IN WHICH PATIENT; APPROX 4 PATIENTS WITH DBS FOR DYSTONIA EXPERIENCED AN INFECTION THAT LED TO THE DBS SYSTEM BEING EXPLANTED. THE AUTHORS NOTED THAT SEVERAL DIFFERENT PATHOGENS WERE DOCUMENTED, INCLUDING: STAPHYLOCOCCUS AUREUS, STAPHYLOCOCCUS EPIDERMIDIS, AND PSEUDOMONAS AERUGINOSA. HOWEVER, IT REMAINS UNCLEAR WHICH PATHOGEN WAS FOUND IN WHICH PATIENT; APPROX 1 PATIENT WITH DBS FOR DYSTONIA EXPERIENCED AN INFECTION/HEALING PROBLEMS THAT WERE DESCRIBED AS ¿REVERSIBLE.¿ THE AUTHORS NOTED THAT SEVERAL DIFFERENT PATHOGENS WERE DOCUMENTED, INCLUDING: STAPHYLOCOCCUS AUREUS, STAPHYLOCOCCUS EPIDERMIDIS, AND PSEUDOMONAS AERUGINOSA. HOWEVER, IT REMAINS UNCLEAR WHICH PATHOGEN WAS FOUND IN WHICH PATIENT; APPROX 1 PATIENT WITH DBS FOR DYSTONIA EXPERIENCED REVERSIBLE ¿DISEASE-RELATED¿ INCREASED SEIZURE FREQUENCY; APPROX 1 PATIENT WITH DBS FOR DYSTONIA REPORTEDLY FAILED TO ADEQUATELY RECHARGE THEIR INS, RESULTING IN ¿IRREVERSIBLE¿ BATTERY DISCHARGE THAT REQUIRED INS REPLACEMENT; APPROX 2 PATIENTS WITH DBS FOR DYSTONIA EXPERIENCED AN ¿IRREVERSIBLE... TECHNICAL DEFECT¿ THAT REQUIRED INS REPLACEMENT; APPROX 2 PATIENTS WITH DBS FOR DYSTONIA EXPERIENCED A LACK OF EFFECT THAT LED TO THE DBS SYSTEM BEING EXPLANTED; APPROX 2 PATIENTS WITH DBS FOR DYSTONIA EXPERIENCED MALPOSITION OR DISLOCATION OF THE DEVICE THAT LED TO THE DBS SYSTEM BEING EXPLANTED; APPROX 3 PATIENTS WITH DBS FOR DYSTONIA UNDERWENT A TOTAL OF 4 LEAD REVISIONS DUE TO DISLOCATION OR ¿TECHNICAL DEFECT.¿ THE AUTHORS REPORTED THAT 12 PATIENTS RECEIVED A RECHARGEABLE IMPLANTABLE NEUROSTIMULATOR (INS), WHEREAS 27 PATIENTS WERE IMPLANTED BY A NON-RECHARGEABLE INS. HOWEVER, IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619938 IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other| R