BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE PC

    MDR report key: 25248281 · Received May 21, 2026

    Report

    Report Number
    3006630150-2026-03357
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    August 2, 2025
    Report Date
    May 21, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: SALAZAR-VILLACORTA A, CAZURRO-GUTIERREZ A, DOUGHERTY-DE MIGUEL L, ET AL. DEEP BRAIN STIMULATION IN CHILDREN AND ADOLESCENTS WITH EPSILON-SARCOGLYCAN MYOCLONUS DYSTONIA CAUSES A SUSTAINED IMPROVEMENT IN MOTOR FUNCTIONALITY AND QUALITY OF LIFE. MOV DISORD. OCT 2025;40(10):2234-2242. WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # FOR THIS PRODUCT. ALL AVAILABLE PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE ARTICLE TITLED DEEP BRAIN STIMULATION IN CHILDREN AND ADOLESCENTS WITH EPSILON-SARCOGLYCAN MYOCLONUS DYSTONIA CAUSES A SUSTAINED IMPROVEMENT IN MOTOR FUNCTIONALITY AND QUALITY OF LIFE THAT ATROPHIC SCARRING OCCURRED. BACKGROUND: DEEP BRAIN STIMULATION OF THE GLOBUS PALLIDUS INTERNUS (DBS-GPI) HAS SHOWN EFFICACY IN ADULT PATIENTS WITH SGCE-RELATED MYOCLONUS DYSTONIA. HOWEVER, EVIDENCE REGARDING ITS IMPACT IN PEDIATRIC POPULATIONS IS LIMITED. OBJECTIVES: THE AIM WAS TO EVALUATE MOTOR AND NONMOTOR OUTCOMES FOLLOWING DBS-GPI INTERVENTION IN CHILDREN AND ADOLESCENTS WITH SGCE-MD. METHODS: TEN PATIENTS (MEAN AGE 12.8 _ 3.4 YEARS) UNDERWENT DBS-GPI. BLINDED EXPERTS RATED PATIENTS WITH THE UNIFIED MYOCLONUS, BURKE-FAHN-MARSDEN, WRITERS CRAMP AND GAIT DYSTONIA RATING SCALES. PSYCHIATRIC AND QUALITY-OF-LIFE OUTCOMES WERE EVALUATED USING THE DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS, FIFTH EDITION CRITERIA AND QUALITY OF LIFE IN NEUROLOGICAL DISORDERS. RESULTS: SIGNIFICANT IMPROVEMENTS WERE OBSERVED IN MYOCLONUS (68.1%), GENERALIZED DYSTONIA (63.2%), AND DYSTONIA DURING WRITING (48.1%), WALKING (70.3%) AND RUNNING (44.2%) AFTER 3.8 _ 2.4 YEARS OF THE SURGERY. PSYCHIATRIC SYMPTOMS REMAINED STABLE, WHILE QUALITY-OF-LIFE ASSESSMENTS REVEALED REDUCTIONS IN ANXIETY, FATIGUE, AND STIGMA (P < 0.05). CONCLUSIONS: DBS-GPI IN CHILDREN WITH SGCE-MYOCLONUS DYSTONIA MITIGATES LONG-TERM DISABILITY, POTENTIALLY ENHANCING ACADEMIC, SOCIAL, AND PROFESSIONAL PROSPECTS. TWO PATIENTS EXPERIENCED ATROPHIC SCARRING THAT WAS MANAGED WITH LOCAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564448 VERCISE PC STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1