BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE PC

    MDR report key: 23126869 · Received September 23, 2025

    Report

    Report Number
    3006630150-2025-07926
    Event Type
    Injury
    Date Received
    September 23, 2025
    Date of Event
    September 14, 2025
    Report Date
    September 23, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    NHL
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE (PRODUCT CODE): MHY, PJS; REPORTED HERE AS THE PRO CODE EXCEEDED THE CHARACTER LIMIT FOR DESIGNATED FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS REQUESTING AN APPOINTMENT WITH THE PHYSICIAN FOR REPROGRAMMING OF THEIR THERAPY DUE TO EXPERIENCING AN EPILEPTIC SEIZURE WHEREIN THEY WERE SEVERELY INJURED DUE TO A FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218126 VERCISE PC STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1140-S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention