BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3244981 · Received July 24, 2013

    Report

    Report Number
    3007566237-2013-02465
    Event Type
    Injury
    Date Received
    July 24, 2013
    Date of Event
    September 5, 2012
    Report Date
    July 10, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. PRODUCT ID: 3387, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    WHITMER, D., DE SOLAGES, C., HILL, B.C., YU, H., BRONTE-STEWART, H. RESTING BETA HYPERSYNCHRONY IN SECONDARY DYSTONIA AND ITS SUPPRESSION DURING PALLIDAL DEEP BRAIN STIMULATION IN DYT3+ LUBAG DYSTONIA. NEUROMODULATION : JOURNAL OF THE INTERNATIONAL NEUROMODULATION SOCIETY. 2013;16(3):200-205. DOI: 10.1111/J.1525-1403.2012.00519.X SUMMARY: OBJECTIVES 1) TO CHARACTERIZE PATTERNS OF GLOBUS PALLIDUS INTERNA NEURAL SYNCHRONY IN PATIENTS WITH SECONDARY DYSTONIA; 2) TO DETERMINE WHETHER NEURAL HYPERSYNCHRONY IN THE GLOBUS PALLIDUS EXTERNA (GPE) AND INTERNA (GPI) IS ATTENUATED DURING HIGH FREQUENCY DEEP BRAIN STIMULATION (HF DBS) IN A PATIENT WITH DYT3+ DYSTONIA AND IN A PATIENT WITH SECONDARY DYSTONIA DUE TO CHILDHOOD ENCEPHALITIS. WE RECORDED LOCAL FIELD POTENTIALS FROM THE DBS LEADIN THE GPI OF FOUR PATIENTS (SEVEN HEMISPHERES) WITH SECONDARY DYSTONIA AND FROM ONE PATIENT (TWO HEMISPHERES) WITH PRIMARY DYT3+ DYSTONIA. IN TWO PATIENTS, WE ALSO RECORDED PALLIDAL LOCAL FIELD POTENTIALS DURING THE ADMINISTRATION OF 10 SEC EPOCHS OF HF DBS. POWER SPECTRAL DENSITIES DURING REST DEMONSTRATED VISIBLE PEAKS IN THE BETA BAND IN SEVEN OUT OF NINE CASES. IN DYT3+ DYSTONIA, POWER IN THE ALPHA AND BETA BANDS, BUT NOT THETA BAND, WAS ATTENUATED DURING HF DBS IN THE GPE AND IN GPI, AND ATTENUATION WAS MOST PROMINENT IN THE HIGH BETA BAND. THIS PATIENT DEMONSTRATED AN EARLY AND MAINTAINED IMPROVEMENT IN DYSTONIA. THERE WAS NO BETA PEAK AND THE POWER SPECTRUM WAS NOT ATTENUATED DURING HF DBS IN A PATIENT WITH SECONDARY DYSTONIA DUE TO CHILDHOOD ENCEPHALITIS. THESE RESULTS SUGGEST THAT BETA HYPERSYNCHRONY, DEMONSTRATED NOW IN BOTH PRIMARY AND SECONDARY DYSTONIA, MAY PLAY A PATHOPHYSIOLOGICAL ROLE IN PATHOLOGICAL HYPERKINESIS. FURTHER INVESTIGATION IS NEEDED IN A LARGER COHORT OF WELL-CHARACTERIZED PRIMARY AND SECONDARY DYSTONIA PATIENTS. REPORTED EVENT: 43-YEAR-OLD WOMAN WITH SECONDARY GENERAL DYSTONIA DUE TO CEREBRAL PALSY HAD LEAD DISPLACEMENT OF THE ACTUAL FROM PLANNED LEAD LOCATION AND AN INFECTION. 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
    346768 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention