BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE? CARTESIA?

    MDR report key: 22689041 · Received August 1, 2025

    Report

    Report Number
    3006630150-2025-06050
    Event Type
    Injury
    Date Received
    August 1, 2025
    Date of Event
    November 1, 2024
    Report Date
    August 1, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: APPROXIMATED BASED ON THE SALES REPRESENTATIVE RESPONSE. BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODES: PJS, NHL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7120703, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT LEAD REPLACEMENT AFTER THE ORIGINAL LEADS WERE FOUND TO BE OFF TARGET, RESULTING IN MINIMAL THERAPEUTIC EFFECT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE IS GOOD. WHILE RIGIDITY SYMPTOMS HAVE IMPROVED COMPARED TO BEFORE, DYSKINESIA HAS LIKELY EMERGED DUE TO THE IMPLANTED POSITION. THE PATIENT WILL CONTINUE TO BE MONITORED. THE EXPLANTED PRODUCTS WERE DISCARDED AT THE FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049672 VERCISE? CARTESIA? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2202-45 7120772 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention