BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 16492901 · Received March 6, 2023

    Report

    Report Number
    3006630150-2023-01064
    Event Type
    Injury
    Date Received
    March 6, 2023
    Date of Event
    October 8, 2020
    Report Date
    March 6, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: 7071179; PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: 7071196.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT WAS ADMITTED WITH SEVERE WORSENING OF PARKINSONS DISEASE. THE PATIENT WAS TREATED WITH MEDICATION AND THE DEVICE WAS REPROGRAMMED. THE PATIENT WAS DISCHARGED AND NO FURTHER ACTION WILL BE TAKEN. ADDITIONALLY, THE PHYSICIAN ASSESSED THE EVENT AS HAVING A POSSIBLE RELATIONSHIP TO STIMULATION, BUT NOT RELATED TO PROCEDURE AND HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706911 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-1200 742368

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention