BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 19015120 · Received April 1, 2024

    Report

    Report Number
    3006630150-2024-01982
    Event Type
    Injury
    Date Received
    April 1, 2024
    Date of Event
    September 21, 2017
    Report Date
    April 1, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905271
    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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202300. MODEL: DB-2202-30. SERIAL: (B)(6). BATCH: 3150706.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED NUMBNESS OF THE RIGHT LOWER LIP AND TONGUE FOLLOWING THE IMPLANT PROCEDURE. IN 2021, THE NUMBNESS STARTED TO FEEL LIKE A BURNING SENSATION. THE PATIENT WAS TREATED WITH BOTOX AND HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517499 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-30 20484033 08714729905271

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R