BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE? CARTESIA?

    MDR report key: 22515604 · Received July 15, 2025

    Report

    Report Number
    3006630150-2025-05543
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    May 12, 2025
    Report Date
    July 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODES: PJS, NHL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7133148, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE INVOLVING COMPLETE REMOVAL OF THE DBS SYSTEM DUE TO EROSION AT THE LEAD AND LEAD EXTENSION SITE. NO SIGNS OF INFECTION WERE FOUND. THE PATIENT WAS REPORTED TO BE AT BASELINE FOLLOWING THE PROCEDURE. THE EXPLANTED COMPONENTS WERE NOT RETURNED FOR ANALYSIS, AS THEY WERE DISPOSED OF BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602253 VERCISE? CARTESIA? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2202-45 7131110 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention