BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 8818524 · Received July 23, 2019

    Report

    Report Number
    3006630150-2019-03766
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    June 25, 2019
    Report Date
    July 23, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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-2202-45, SERIAL: (B)(4), BATCH: 5070093. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: (B)(4), MODEL: DB-2202-45, SERIAL:(B)(4), BATCH: 5075915. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HOSPITALIZED DUE TO SERIOUS PSYCHIATRIC ISSUES. THE PATIENT WAS ADMINISTERED SEDATION AND ANTI-PSYCHOTIC MEDICATIONS AND WAS INVOLUNTARILY ADMITTED INTO PSYCHIATRIC CARE FOR 6 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611591 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-1200 737078

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization