BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2780905 · Received October 10, 2012

    Report

    Report Number
    3007566237-2012-02429
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    April 9, 2012
    Report Date
    September 11, 2012
    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

    PRODUCT ID (B)(4), LOT#, SERIAL# UNKNOWN, IMPLANTED:, EXPLANTED:. PRODUCT TYPE LEAD. 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. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. (B)(4).

    Description of Event or Problem · 1

    MARKUN, L. C., STARR, P. A., AIR, E. L., MARKS, W. J. JR., VOLZ, M. M., OSTREM, J. L. SHORTER DISEASE DURATION CORRELATES WITH IMPROVED LONG-TERM DEEP BRAIN STIMULATION OUTCOMES IN YOUNG-ONSET DYT1 DYSTONIA. NEUROSURGERY; 2012 AUG 2012;71(2):325-330. DOI: 10.1227/ NEU.0B013E318258E21B. SUMMARY: TREATMENT WITH DEEP BRAIN STIMULATION (DBS) OF THE GLOBUS PALLIDUS INTERNUS IN CHILDREN WITH DYT1 PRIMARY TORSION DYSTONIA IS HIGHLY EFFECTIVE; HOWEVER, INDIVIDUAL RESPONSE TO STIMULATION IS VARIABLE, AND A GREATER UNDERSTANDING OF PREDICTORS OF LONG-TERM OUTCOME IS NEEDED. THE OBJECTIVE WAS TO REPORT THE LONG-TERM OUTCOMES OF SUBJECTS WITH YOUNG-ONSET DYT1 PRIMARY TORSION DYSTONIA TREATED WITH BILATERAL GLOBUS PALLIDUS DBS. FOURTEEN SUBJECTS (7 MALE, 7 FEMALE) TREATED CONSECUTIVELY FROM 2000 TO 2010, AT OUR CENTER WERE INCLUDED IN THIS RETROSPECTIVE STUDY. THE BURKE-FAHN-MARSDEN DYSTONIA RATING SCALE WAS PERFORMED AT BASELINE AND AT 1, 2, AND UP TO 6 YEARS POSTOPERATIVELY. PALLIDAL DBS WAS WELL TOLERATED AND HIGHLY EFFECTIVE, WITH MEAN BURKE-FAHN-MARSDEN DYSTONIA RATING SCALE MOVEMENT SCORES IMPROVING FROM BASELINE BY 61.5% (P , .001) AT 1 YEAR, 64.4% (P , .001) AT 2 YEARS, AND 70.3% (P , .001) AT THE FINAL FOLLOW-UP VISIT (MEAN, 32 MONTHS; RANGE, 7-77 MONTHS). DISABILITY SCORES ALSO IMPROVED SIGNIFICANTLY. MULTIPLE LINEAR REGRESSION ANALYSIS REVEALED A SIGNIFICANT INFLUENCE OF DURATION OF DISEASE AS A PREDICTOR OF PERCENT IMPROVEMENT IN BURKE-FAHN-MARSDEN DYSTONIA RATING SCALE MOVEMENT SCORE AT LONG-TERM FOLLOW-UP (DURATION OF DISEASE, P , .05). SUBJECTS WITH FIXED ORTHOPEDIC DEFORMITIES (4) HAD LESS IMPROVEMENT IN THESE REGIONS. LOCATION OF THE ACTIVE DBS ELECTRODE USED AT FINAL FOLLOW-UP VISIT WAS NOT PREDICTIVE OF CLINICAL OUTCOME. OUR FINDINGS HIGHLIGHT THE SUSTAINED BENEFIT FROM DBS AND THE IMPORTANCE OF EARLY REFERRAL FOR DBS IN CHILDREN WITH MEDICALLY REFRACTORY DYT1 PRIMARY TORSION DYSTONIA, WHICH CAN LEAD TO IMPROVED LONG-TERM BENEFITS. REPORTED EVENT: A (B)(6) MALE UNDERWENT STEREOTACTIC LEAD REPOSITIONING. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00012 YR Required Intervention