BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 17343567 · Received July 18, 2023

    Report

    Report Number
    3006630150-2023-04195
    Event Type
    Injury
    Date Received
    July 18, 2023
    Date of Event
    June 22, 2023
    Report Date
    July 18, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600C SERIAL: N/A BATCH: 31084869 PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7102603. PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB12160 , MODEL: DB-1216, SERIAL: (B)(6), BATCH: 563056. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB312855B0, MODEL: DB-3128-55B, SERIAL: (B)(6), BATCH: 5000667. PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: (B)(6), BATCH: 31173549.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT HAD A CYST ON THE TIP OF THE LEAD. THE LEAD AND BURR HOLE COVER WERE EXPLANTED. CULTURES WERE TAKEN AND CONFIRMED INFECTION. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. POST OPERATIVELY, THE PATIENT WAS STABLE. A FEW DAYS LATER, THE REMAINING DEVICES OF THE DEEP BRAIN STIMULATION SYSTEM WERE ALSO EXPLANTED. THE PATIENT IS RECOVERING AND BACK TO THEIR BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862246 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7102583 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention