BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 16488288 · Received March 6, 2023

    Report

    Report Number
    3006630150-2023-01048
    Event Type
    Injury
    Date Received
    March 6, 2023
    Date of Event
    February 22, 2023
    Report Date
    March 6, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(4). LOT: 7092430. PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: N/A. LOT: 28135579.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION WITH PUS AT THE DEEP BRAIN STIMULATION (DBS) LEAD AND BURR HOLE COVER SITE ON THE RIGHT SIDE OF THEIR HEAD. THE PATIENT WAS ADMINISTERED INTRAVENOUS ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE OF THE LEADS AND BURR HOLE COVERS. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550391 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7088670 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention