BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE? CARTESIA?

    MDR report key: 23610791 · Received November 20, 2025

    Report

    Report Number
    3006630150-2025-10617
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    October 31, 2025
    Report Date
    November 20, 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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATION - BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODE: 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: 7133157 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A REVISION PROCEDURE DUE TO INADEQUATE STIMULATION. THE ORIGINAL LEADS HAD BEEN PLACED BILATERALLY IN THE INTERNAL CAPSULE, WHICH LIMITED THE EFFECTIVENESS OF THE STIMULATION. THE PATIENT'S SYMPTOMS INCLUDED DISCOMFORT AND MUSCLE TIGHTNESS WHEN THE STIMULATION WAS ON. THE LEAD REPLACEMENT WAS COMPLETED SUCCESSFULLY AND WITHOUT COMPLICATIONS. THE PATIENT IS DOING WELL POSTOPERATIVELY, WITH NO SIDE EFFECTS. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO BOSTON SCIENTIFIC, AS THEY WERE RETAINED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2474840 VERCISE? CARTESIA? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2202-45 7133304 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention