BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE? CARTESIA? X

    MDR report key: 23918953 · Received December 29, 2025

    Report

    Report Number
    3006630150-2025-11757
    Event Type
    Injury
    Date Received
    December 29, 2025
    Date of Event
    May 20, 2025
    Report Date
    December 29, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    PJS
    UDI-DI
    08714729966340
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION UPN: M365DB3216550 MODEL: DB-3216-55 SERIAL: (B)(6) BATCH: 5001716 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS EVALUATED IN CLINIC FOR DEVICE REPROGRAMMING DUE TO RECURRENCE OF TREMOR IN THE RIGHT HAND. HIGH IMPEDANCE MEASUREMENTS WERE OBSERVED DURING THE ASSESSMENT. THE PATIENT REPORTED EXPERIENCING SEVERAL FALLS, ONE OF WHICH REQUIRED A VISIT TO URGENT CARE. THESE INCIDENTS WERE NOT BELIEVED TO BE RELATED TO THE DBS DEVICE BUT MAY HAVE CONTRIBUTED TO THE IMPEDANCE ISSUE. IMAGING OF THE LEAD AND LEAD EXTENSION SITE REVEALED A MISALIGNMENT AT THE CONNECTION. THE SURGEON OPTED TO MANIPULATE THE EXTENSION CONNECTION THROUGH THE SKIN, UNDER X-RAY GUIDANCE. PROPER ALIGNMENT BETWEEN THE LEAD AND EXTENSION WAS CONFIRMED THROUGH IMAGING AND IMPEDANCE TESTING VIA THE IMPLANTABLE PULSE GENERATOR (IPG). FOLLOWING THE PROCEDURE, IMPEDANCE LEVELS WERE WITHIN NORMAL RANGE. THE PATIENT IS RECEIVING EFFECTIVE THERAPY WITH GOOD SYMPTOM CONTROL. THE PATIENT WAS DISCHARGED HOME AND CONTINUES TO DO WELL. NO DEVICE RETURN IS EXPECTED, AS THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2000389 VERCISE? CARTESIA? X STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS PJS BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2203-45 5003189 08714729966340

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention