BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE? CARTESIA?

    MDR report key: 23952700 · Received January 2, 2026

    Report

    Report Number
    3006630150-2026-00024
    Event Type
    Injury
    Date Received
    January 2, 2026
    Date of Event
    September 1, 2024
    Report Date
    January 2, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATION: THE EVENT DATE IS AROUND (B)(6) 2024, (LATE FALL). BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODE: NHL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7110034. UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB312855B0. MODEL: DB-3128-55B. SERIAL: (B)(6). BATCH: 5001731. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A FULL SYSTEM EXPLANT DUE TO INFECTION AT THE CONNECTOR SITE. THE PATIENT EXPERIENCED WOUND DEHISCENCE, RESULTING IN EXPOSED HARDWARE. THE PHYSICIAN'S ASSESSMENT REGARDING THE INFECTION INDICATED THAT IT WAS NOT DEVICE RELATED BUT ASSOCIATED WITH CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) USE. THE PATIENT USED A CPAP MACHINE WITH STRAPS THAT WENT AROUND THE HEAD, WHICH REQUIRED NIGHTLY APPLICATION AND REMOVAL. THIS REPEATED ACTION CAUSED IRRITATION AT THE CONNECTOR SITE AND ULTIMATELY LED TO HARDWARE EXPOSURE. THE PATIENT WAS PLACED ON ANTIBIOTICS, AND CULTURES REVEALED A BACTERIAL INFECTION. A WASHOUT PROCEDURE WAS PERFORMED IN AN ATTEMPT TO SALVAGE THE HARDWARE; HOWEVER, THIS FAILED AFTER SIX WEEKS OF ANTIBIOTIC THERAPY, NECESSITATING A FULL EXPLANT. THE PATIENT WAS REIMPLANTED ONE YEAR POST EXPLANT TO ENSURE RESOLUTION OF THE INFECTION. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO BOSTON SCIENTIFIC, AS THEY WERE DISCARDED AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12736 VERCISE? CARTESIA? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2202-45 7106764 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention