BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 8064188 · Received November 13, 2018

    Report

    Report Number
    3007566237-2018-03305
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    July 17, 2018
    Report Date
    November 13, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. SANGER, TD., LIKER, M., ARGUELLES, E., DESHPANDE, R., MASKOOKI, A., FERMAN, D., TONGOL, A., ROBISON, A. PEDIATRIC DEEP BRAIN STIMULATION USING AWAKE RECORDING AND STIMULATION FOR TARGET SELECTION IN AN INPATIENT NEUROMODULATION MONITORING UNIT. BRAIN SCI. 2018;8(7). DOI:10.3390/BRAINSCI8070135. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: DEEP BRAIN STIMULATION (DBS) FOR SECONDARY (ACQUIRED, COMBINED) DYSTONIA DOES NOT REACH THE HIGH DEGREE OF EFFICACY ACHIEVED IN PRIMARY (GENETIC, ISOLATED) DYSTONIA. WE HYPOTHESIZE THAT THIS MAY BE DUE TO VARIABILITY IN THE UNDERLYING INJURY, SO THAT DIFFERENT CHILDREN MAY REQUIRE PLACEMENT OF ELECTRODES IN DIFFERENT REGIONS OF BASAL GANGLIA AND THALAMUS. WE DESCRIBE A NEW TARGETING PROCEDURE IN WHICH TEMPORARY DEPTH ELECTRODES ARE PLACED AT MULTIPLE POSSIBLE TARGETS IN BASAL GANGLIA AND THALAMUS, AND PROBING FOR EFFICACY IS PERFORMED USING TEST STIMULATION AND RECORDING WHILE CHILDREN REMAIN FOR ONE WEEK IN AN INPATIENT NEUROMODULATION MONITORING UNIT (NMU). NINE CHILDREN WITH SEVERE SECONDARY DYSTONIA UNDERWENT THE NMU TARGETING PROCEDURE. IN ALL CASES, 4 ELECTRODES WERE IMPLANTED. WE COMPARED THE RESULTS TO 6 CHILDREN WHO HAD PREVIOUSLY HAD 4 ELECTRODES IMPLANTED USING STANDARD INTRAOPERATIVE MICROELECTRODE TARGETING TECHNIQUES. RESULTS SHOWED A SIGNIFICANT BENEFIT, WITH 80% OF CHILDREN WITH NMU TARGETING ACHIEVING GREATER THAN 5-POINT IMPROVEMENT ON THE BURKE¿FAHN¿MARSDEN DYSTONIA RATING SCALE (BFMDRS), COMPARED WITH 50% OF CHILDREN USING INTRAOPERATIVE TARGETING. NMU TARGETING IMPROVED BFMDRS BY AN AVERAGE OF 17.1 WHEREAS INTRAOPERATIVE TARGETING IMPROVED BY AN AVERAGE OF 10.3. THESE PRELIMINARY RESULTS SUPPORT THE USE OF TEST STIMULATION AND RECORDING IN A NEUROMODULATION MONITORING UNIT (NMU) AS A NEW TECHNIQUE WITH THE POTENTIAL TO IMPROVE OUTCOMES FOLLOWING DBS IN CHILDREN WITH SECONDARY (ACQUIRED) DYSTONIA. A LARGER SAMPLE SIZE WILL BE NEEDED TO CONFIRM THESE RESULTS. REPORTED EVENTS: A PATIENT WHO RECEIVED BILATERAL DBS OF THE GPI FOR DYSTONIA EXPERIENCED A WOUND INFECTION CAUSED BY MECHANICAL TRAUMA TO THE SURGICAL SITE PRIOR TO COMPLETE HEALING. PATIENTS WERE REPORTEDLY IMPLANTED WITH 37601 ACTIVA PC OR 37612 ACTIVA RC NEUROSTIMULATOR(S), 7483 MODEL EXTENSION(S) AND 3387 MODEL LEADS. IT WAS NOT POSSIBLE TO ASCERTAIN ANY ADDITIONAL SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907117 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other