BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 17738210 · Received September 13, 2023

    Report

    Report Number
    3006630150-2023-05531
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    April 27, 2022
    Report Date
    September 13, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION: UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7060335. PRODUCT FAMILY: DBS-LEAD FIXATION: UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: N/A. BATCH: 24068724.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HIGH IMPEDANCES WERE NOTED ON THE PATIENTS DEEP BRAIN STIMULATION (DBS) LEAD CAUSING INADEQUATE THERAPY AND THE PATIENTS PARKINSONS SYMPTOMS OF TREMORS IN THE RIGHT HAND, HEAD AND VOCAL TO RETURN. COMPUTERIZED TOMOGRAPHY SCAN (CT SCAN) WAS PERFORMED, AND NO FRACTURES WERE IDENTIFIED AND CONFIRMED THE PLACEMENT OF THE DEVICE. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEAD, LEAD EXTENSION AND BURR HOLE COVER WERE REPLACED AND IS DOING WELL POST OPERATIVELY. PHYSICAL ANALYSIS OF THE DBS LEAD, LEAD EXTENSION AND BURR-HOLE COVER WAS NOT PERFORMED AS THEY WERE RETAINED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88144 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 5172931 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention