BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 19067831 · Received April 8, 2024

    Report

    Report Number
    3006630150-2024-02170
    Event Type
    Injury
    Date Received
    April 8, 2024
    Date of Event
    March 20, 2023
    Report Date
    April 8, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7110305.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT CONTINUED TO HAVE ONGOING TREMOR ONE YEAR AFTER IMPLANT. REPROGRAMMING OF THE DEVICE WAS UNSUCCESSFUL. THE PATIENT UNDERWENT A REVISION PROCEDURE TO CORRECT PLACEMENT. DURING THE REVISION THE LEAD AND LEAD EXTENSION WERE REPLACED. NO DEVICE ISSUES WERE SUSPECTED. THE EXPLANTED DEVICES WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104259 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7100353 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention