BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 20043819 · Received August 22, 2024

    Report

    Report Number
    3006630150-2024-05514
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 1, 2022
    Report Date
    August 22, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN JULY 2022. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 5027065. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 5068845. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7011944. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7025054. PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: (B)(6). BATCH: 22116742. PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: (B)(6). BATCH: 22122396.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE THERAPY AND THE RETURN OF THEIR CERVICAL DYSTONIA FROM THEIR DEEP BRAIN STIMULATION (DBS) SYSTEM. ATTEMPTS TO REPROGRAM THE DBS WERE MADE, HOWEVER WERE UNSUCCESSFUL. IT WAS NOTED THAT THE INITIAL PLACEMENT OF THE DBS IN THE GLOBUS PALLIDUS INTERNUS (GPI) BRAIN AREA AND PROGRESSION OF THEIR SYMPTOMS CONTRIBUTED TO THE INADEQUATE THERAPY PER THE PHYSICIANS ASSESSMENT. THE PATIENT UNDERWENT A PROCEDURE WHERE THE DBS LEADS WERE REMOVED, AND NEW LEADS WERE PLACED IN THE SUBTHALAMIC NUCLEUS (STN) BRAIN AREA IN ADDITION TO THE REMAINING DBS DEVICES REPLACED WITH OTHERS OF THE SAME MODEL BEFORE COMPLETING THE PROCEDURE. PHYSICAL ANALYSIS OF THE DBS SYSTEM WAS NOT PERFORMED AS THEY WERE DISCARDED BY THE FACILITY. THE PATIENT DID WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311837 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-1200 736617

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention