BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5651510 · Received May 12, 2016

    Report

    Report Number
    3007566237-2016-01962
    Event Type
    Injury
    Date Received
    May 12, 2016
    Date of Event
    March 1, 2003
    Report Date
    May 12, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. INFORMATION REFERENCES THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PLEASE NOTE THAT THE FOLLOWING DEVICE SPECIFICS WERE NOTED IN THE ARTICLE: LEAD MODEL 3389 AND IMPLANTABLE NEUROSTIMULATORS ITREL II AND ITREL III.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CIF, L., EL FERTIT, H., VAYSSIERE, N., HEMM, S., HARDOUIN, E., GANNAU, A., TUFFERY, S., COUBES, P. TREATMENT OF DYSTONIC SYNDROMES BY CHRONIC ELECTRICAL STIMULATION OF THE INTERNAL GLOBUS PALLIDUS. J NEUROSURG SCI. 2003. 47:1 (52-55). SUMMARY: DYSTONIA IS A MEDICALLY INTRACTABLE CONDITION CAUSING TWISTING OR MYOCLONIC MOVEMENTS AND ABNORMAL POSTURES. THERE IS AN IMPORTANT HETEROGENEITY AMONG ETIOLOGIES OF DYSTONIA. THE ELECTRICAL STIMULATION OF THE GLOBUS PALLIDUS HAS BEEN USED SUCCESSFULLY IN PRIMARY GENERALIZED DYSTONIA. THE AIM OF THIS STUDY WAS TO EXAMINE THE LONG-TERM EFFICACY AND SAFETY OF DEEP BRAIN STIMULATION (DBS) IN THE TREATMENT OF PRIMARY AND SECONDARY GENERALIZED DYSTONIA IN CHILDREN AND ADULTS. REPORTED EVENTS: 3 PATIENTS WITH GLOBUS PALLIDUS INTERNUS(GPI) DEEP BRAIN STIMULATION (DBS) FOR DYSTONIA EXPERIENCED SECONDARY INFECTION OF THE STIMULATION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304716 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other