BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 16363843 · Received February 13, 2023

    Report

    Report Number
    3006630150-2023-00561
    Event Type
    Injury
    Date Received
    February 13, 2023
    Date of Event
    January 19, 2023
    Report Date
    February 13, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7087048; PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, BATCH: 27487994; PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, BATCH: 27845127; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7091915; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7096507.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DEEP BRAIN STIMULATION PATIENT'S RIGHT LEAD, LEAD EXTENSION, AND BURR HOLE COVER WERE EXPLANTED DUE TO IMPAIRED HEALING AND EROSION WHERE THE LEAD WAS PLACED IN THE SCALP. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO BSC FOR ANALYSIS AS THEY WERE KEPT BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517365 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7085106 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention