BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 18685280 · Received February 12, 2024

    Report

    Report Number
    3006630150-2024-00620
    Event Type
    Injury
    Date Received
    February 12, 2024
    Date of Event
    January 9, 2024
    Report Date
    February 12, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905271
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202300 MODEL: DB-2202-30 SERIAL: (B)(6) BATCH: 7082284. PRODUCT FAMILY: DBS-IPG-R-MRI UPN: M365DB12160 MODEL: DB-1216 SERIAL: (B)(6) BATCH: 580144. PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: (B)(6) BATCH: 7119510 PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: (B)(6). BATCH: 7119707 PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600C SERIAL: N/A BATCH: 32163748 PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600C SERIAL: N/A BATCH: 32163751.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION AT THE LEAD IMPLANT SITE AND UNDERWENT AN EXPLANT OF THE DBS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298880 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-30 7079054 08714729905271

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention