BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE PC

    MDR report key: 11375716 · Received February 24, 2021

    Report

    Report Number
    3006630150-2021-00623
    Event Type
    Injury
    Date Received
    February 24, 2021
    Date of Event
    October 1, 2020
    Report Date
    February 24, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: 5107733. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: 5107652.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CLINICAL STUDY PATIENT, (B)(6) STUDY, DEVELOPED MILD REM SLEEP BEHAVIOR AND WAS TREATED WITH MEDICATION. THE EVENT WAS ASSESSED AS POSSIBLY RELATED TO STIMULATION AND NOT RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267874 VERCISE PC STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-1140 630532

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention