BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 20849992 · Received December 4, 2024

    Report

    Report Number
    3006630150-2024-08386
    Event Type
    Injury
    Date Received
    December 4, 2024
    Date of Event
    November 11, 2024
    Report Date
    December 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL PRO CODES IN D2B: NHL, PJS ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(4) BATCH: 7117969 PRODUCT FAMILY: DBS-EXTENSION UPN: M365DB312855B0 MODEL: DB-3128-55B SERIAL: (B)(6) BATCH: 5002408.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED EROSION AND INFECTION AT THE SCALPS LEAD IMPLANT SITE. IT WAS NOTED THAT THE DBS LEAD WAS EXPOSED AT THE LEAD EXTENSION HEADER SITE PER THE PHYSICIANS ASSESSMENT, HOWEVER THE CAUSE FOR THE EROSION IS NOT KNOWN AND CULTURES WERE NOT TAKEN. THE PATIENT UNDERWENT A PROCEDURE WHERE THE DBS LEADS, AND LEAD EXTENSION WERE REPLACED WITH OTHERS OF THE SAME MODEL. PHYSICAL ANALYSIS OF THE DBS LEADS, AND LEAD EXTENSION WAS NOT PERFORMED AS THEY WERE DISPOSED BY THE FACILITY. THE PATIENT DID WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1871696 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2202-45 7118664 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention