BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE? CARTESIA?

    MDR report key: 23918961 · Received December 29, 2025

    Report

    Report Number
    3006630150-2025-11758
    Event Type
    Injury
    Date Received
    December 29, 2025
    Date of Event
    February 29, 2024
    Report Date
    December 29, 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
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6) BATCH: 7113272 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH DEEP BRAIN STIMULATION (DBS) EXPERIENCED INADEQUATE SYMPTOM CONTROL AND RECURRENCE OF TREMORS. MULTIPLE REPROGRAMMING ATTEMPTS WERE UNSUCCESSFUL. THE PHYSICIAN DETERMINED THAT LEAD MIGRATION HAD NOT OCCURRED; RATHER, THE INITIAL LEAD PLACEMENT WAS SUBOPTIMAL FOR TREMOR MANAGEMENT. THE PATIENT UNDERWENT REVISION SURGERY, DURING WHICH THE ORIGINAL LEADS WERE REMOVED AND REPLACED IN A MORE APPROPRIATE LOCATION. LEAD ANALYSIS WAS NOT PERFORMED, AS THE FACILITY RETAINED THEM PER POLICY. THE PATIENT RECOVERED WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2326968 VERCISE? CARTESIA? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2202-45 7113225 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention