BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE? CARTESIA?

    MDR report key: 23397330 · Received October 27, 2025

    Report

    Report Number
    3006630150-2025-09625
    Event Type
    Injury
    Date Received
    October 27, 2025
    Date of Event
    April 2, 2025
    Report Date
    October 27, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7119476, UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB312855B0, MODEL: DB-3128-55B, SERIAL: (B)(6), BATCH: 5003012, UDI: (B)(4). PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB12160, MODEL: DB-1216, SERIAL: (B)(6), BATCH: 757465, UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600-C, SERIAL: N/A, BATCH: 33612497, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED EXTRUSION WITH THE POTENTIAL RISK OF INFECTION AT THE LEAD AND LEAD EXTENSION IMPLANT SITE. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE DBS SYSTEM WAS EXPLANTED. THE PHYSICIAN ASSESSED THAT THE CAUSE FOR THE EXTRUSION COULD NOT BE DETERMINED. ANALYSIS OF THE DBS DEVICES WAS NOT PERFORMED AS THEY WERE RETAINED BY THE FACILITY. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND HAS MADE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2734397 VERCISE? CARTESIA? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2202-45 7119468 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention