BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 15577784 · Received October 11, 2022

    Report

    Report Number
    3006630150-2022-05435
    Event Type
    Injury
    Date Received
    October 11, 2022
    Date of Event
    August 3, 2022
    Report Date
    October 10, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: VERCISE CARTESIA: UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(4). BATCH: 7090532.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED BRAIN EDEMA AND SWELLING NEAR THE DEEP BRAIN STIMULATION LEADS. THE PATIENT EXPERIENCED BALANCE AND COORDINATION ISSUES SINCE THE IMPLANT PROCEDURE AND THEREFORE, THE DEVICE HAD BEEN TURNED OFF SINCE THE IMPLANT PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT TWO MAGNETIC RESONANCE IMAGES. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2764220 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7090317 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| H| R