BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 20957140 · Received December 17, 2024

    Report

    Report Number
    3006630150-2024-08844
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    November 14, 2024
    Report Date
    December 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    PJS
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE - MHY. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6). BATCH: 7122423 PRODUCT FAMILY: DBS-IPG-R-MRI UPN: M365DB12160 MODEL: DB-1216 SERIAL: 764165 BATCH: 764165 PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600-C SERIAL: NULL BATCH: 33817239 PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600-C SERIAL: NULL BATCH: 32697186 PRODUCT FAMILY: DBS-EXTENSION UPN: M365DB312855B0 MODEL: DB-3128-55B SERIAL: (B)(6) BATCH: 5001306.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION AT THE SITE OF THE SCALP WHEREIN PRESENTING SYMPTOMS OF PUSS AND SWELLING. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS EXPLANTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED DEVICES WERE DISPOSED AT THE MEDICAL FACILITY AND WERE NOT RETURNED TO BSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438524 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR PJS BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2202-45 7115507

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention