BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE? CARTESIA? X

    MDR report key: 23754015 · Received December 9, 2025

    Report

    Report Number
    3006630150-2025-11281
    Event Type
    Injury
    Date Received
    December 9, 2025
    Date of Event
    November 14, 2025
    Report Date
    December 9, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    PJS
    UDI-DI
    08714729966340
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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: M365DB2203450, MODEL: DB-2203-45, SERIAL: (B)(6), BATCH: 5002764, UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION UPN: M365DB3216550, MODEL: DB-3216-55, SERIAL: (B)(6), BATCH: 5001273, UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION UPN: M365DB3216550, MODEL: DB-3216-55, SERIAL: (B)(6), BATCH: 5001298, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE ENTIRE SYSTEM DUE TO INFECTION. THE PATIENT SUFFERED A VASOVAGAL SYNCOPE AT HOME, NOT RELATED TO STIMULATION OR THE DEVICE, AND SUSTAINED A HEAD INJURY AS A RESULT OF THE FALL. THE WOUND WAS LOCATED IN THE AREA OF THE LEAD/LEAD EXTENSION JUNCTURE AND SUBSEQUENTLY BECAME INFECTED. THE SYMPTOMS THE PATIENT EXPERIENCED INCLUDED REDNESS, SWELLING, AND FLUID DISCHARGE. THE PATIENT WAS PLACED ON AN ANTIBIOTIC REGIMEN; HOWEVER, THE SURGEON DETERMINED THAT EXPLANTATION OF THE DEVICE WAS NECESSARY. THE PATIENT IS RECOVERING NORMALLY FOLLOWING THE EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE DISPOSED OF BY THE HOSPITAL AND WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2813832 VERCISE? CARTESIA? X STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS PJS BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2203-45 5003337 08714729966340

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention