BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERCISE? CARTESIA?

    MDR report key: 22835841 · Received August 18, 2025

    Report

    Report Number
    3006630150-2025-06636
    Event Type
    Death
    Date Received
    August 18, 2025
    Date of Event
    July 24, 2025
    Report Date
    August 18, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729905271
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D.2B; ADDITIONAL APPLICABLE PRODUCT CODES: NHL, PJS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202300 MODEL: DB-2202-30 SERIAL: (B)(6) BATCH: 7086026 UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600-C BATCH: 36122989 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN IMPLANT SURGERY. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED A POST-OPERATIVE HEMORRHAGE. DUE TO AN ADVANCED DIRECTIVE IN PLACE, WHICH PROHIBITS LIFE-SAVING SURGICAL INTERVENTIONS, THE PATIENT UNFORTUNATELY PASSED AWAY. THE SURGEON HAS CLEARLY STATED THAT THE EVENT WAS NOT RELATED TO THE DEVICE, AND IT IS UNCERTAIN WHETHER IT WAS RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2204807 VERCISE? CARTESIA? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2202-30 7086286 08714729905271

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death