BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 11343915 · Received February 18, 2021

    Report

    Report Number
    3006630150-2021-00540
    Event Type
    Injury
    Date Received
    February 18, 2021
    Date of Event
    August 22, 2020
    Report Date
    February 18, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: 7071098. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: 7071096.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT DEVELOPED A WORSENING OF PARKINSON'S DISEASE. THE PATIENT WAS ADMITTED INTO THE HOSPITAL AND WAS TREATED WITH MEDICATION AND STIMULATION WAS ADJUSTED. THE ISSUE WAS RESOLVED AND THE PATIENT WAS DISCHARGED. THE PHYSICIAN ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO STIMULATION AND WAS NOT RELATED TO HARDWARE AND PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241823 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-1200 742381

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R