BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 15451979 · Received September 19, 2022

    Report

    Report Number
    3006630150-2022-04870
    Event Type
    Injury
    Date Received
    September 19, 2022
    Date of Event
    January 1, 2020
    Report Date
    September 19, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(4). BATCH: 5148677. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(4). BATCH: 5153264.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT, A4010 DBS VERCISE REGISTRY, DEVELOPED MODERATE HYPERSEXUALITY IMPULSE DISORDER AND TREATED WITH MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2694521 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-1200 738768

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention