BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 19444909 · Received June 2, 2024

    Report

    Report Number
    3006630150-2024-03562
    Event Type
    Injury
    Date Received
    June 2, 2024
    Date of Event
    May 8, 2024
    Report Date
    June 2, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: DATE OF EVENT UNKNOWN. APPROXIMATED BASED ON DATE THE MANUFACTURER BECOMING AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7031195. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7036735.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE THERAPY FOR HER HEMIBALLISMUS. ATTEMPTS TO REPROGRAM THE DBS DEVICE WERE MADE, HOWEVER WERE UNSUCCESSFUL. IT WAS NOTED THAT THE DBS WAS USED TO TREAT FOR AN OFF-LABEL USE AND PERFORMED AS EXPECTED HOWEVER THE PATIENT DID NOT RECEIVE ADEQUATE THERAPY AND ELECTED TO REMOVE THE DBS PER THE PHYSICIANS ASSESSMENT. THE PATIENT UNDERWENT A PROCEDURE WHERE THE DBS IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD EXTENSIONS WERE REMOVED. PHYSICAL ANALYSIS OF THE DBS IPG AND LEAD EXTENSIONS WAS NOT PERFORMED AS THEY WERE DISPOSED BY THE FACILITY. THE PATIENT DID WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1884145 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 737022 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Required Intervention