BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 6281662 · Received January 26, 2017

    Report

    Report Number
    3007566237-2017-00307
    Event Type
    Malfunction
    Date Received
    January 26, 2017
    Date of Event
    March 1, 2016
    Report Date
    January 26, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEMS INVOLVED IN THE REPORTED EVENT; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    RODRIGUEZ CRUZ, PM., VARGAS, A., FERNANDEZ-CARBALLAL, C., GARBIZU, J., DE LA CASA-FAGES, B., GRANDAS, F. LONG-TERM THALAMIC DEEP BRAIN STIMULATION FOR ESSENTIAL TREMOR: CLINICAL OUTCOME AND STIMULATION PARAMETERS. MOVEMENT DISORDERS CLINICAL PRACTICE. 2016;3(6):567-572. SUMMARY: BACKGROUND: THE REASONS UNDERLYING THE LOSS OF EFFICACY OF DEEP BRAIN STIMULATION (DBS) OF THE THALAMIC NUCLEUS VENTRALIS INTERMEDIUS (VIM-DBS) OVER TIME IN PATIENTS WITH ESSENTIAL TREMOR ARE NOT WELL UNDERSTOOD. METHODS: LONG-TERM CLINICAL OUTCOME AND STIMULATION PARAMETERS WERE EVALUATED IN 14 PATIENTS WITH ESSENTIAL TREMOR WHO UNDERWENT VIM-DBS. THE MEAN STANDARD DEVIATION POSTOPERATIVE FOLLOW-UP WAS 7.7±3.8 YEARS. AT EACH VISIT (EVERY 3¿6 MONTHS), TREMOR WAS ASSESSED USING THE FAHN-TOLOSA-MARIN TREMOR RATING SCALE (FTM-TRS) AND STIMULATION PARAMETERS WERE RECORDED (CONTACTS, VOLTAGE, FREQUENCY, PULSE WIDTH, AND TOTAL ELECTRICAL ENERGY DELIVERED BY THE INTERNAL GENERATOR [TEED1SEC]). RESULTS: THE MEAN REDUCTION IN FTM-TRS SCORE WAS 73.4% AT 6 MONTHS AFTER VIM-DBS SURGERY (P <(><<)> 0.001) AND 50.1% AT THE LAST VISIT (P <(><<)> 0.001). THE GRADUAL WORSENING OF FTM-TRS SCORES OVER TIME FIT A LINEAR REGRESSION MODEL (COEFFICIENT OF DETERMINATION [R2] = 0.887; P <(><<)> 0.001). STIMULATION ADJUSTMENTS TO OPTIMIZE TREMOR CONTROL REQUIRED A STATISTICALLY SIGNIFICANT INCREASE IN VOLTAGE (P = 0.01), PULSE WIDTH (P = 0.01), FREQUENCY (P = 0.02), AND TEED1SEC (P = 0.008). TEED1SEC FIT A THIRD-ORDER POLYNOMIAL CURVE MODEL THROUGHOUT THE FOLLOWUP PERIOD (R2 = 0.966; P <(><<)> 0.001). THE INITIAL EXPONENTIAL INCREASE (FIRST 4 YEARS OF VIM-DBS) WAS FOLLOWED BY A PLATEAU AND A FURTHER INCREASE FROM THE SEVENTH YEAR ONWARD. CONCLUSIONS: THE CURRENT FINDINGS SUGGEST THAT THE WANING EFFECT OF VIM-DBS OVER TIME IN PATIENTS WITH ESSENTIAL TREMOR MAY BE THE CONSEQUENCE OF A COMBINATION OF FACTORS. SUPERIMPOSED ON THE PROGRESSION OF THE DISEASE, TOLERANCE CAN OCCUR DURING THE EARLY YEARS OF STIMULATION. REPORTED EVENT: 2 PATIENTS WHO RECEIVED VIM-DBS FOR ESSENTIAL TREMOR WERE EXCLUDED FROM THE STUDY BECAUSE THEY EXPERIENCED NO/POOR THERAPEUTIC BENEFIT AFTER INITIAL PROGRAMMING DUE TO ¿SUBOPTIMAL¿ PLACEMENT OF THE ELECTRODES. 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
    64142 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1