BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 11166901 · Received January 13, 2021

    Report

    Report Number
    3006630150-2020-06682
    Event Type
    Injury
    Date Received
    January 13, 2021
    Date of Event
    December 11, 2020
    Report Date
    January 13, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7073329. PRODUCT FAMILY: DBS-IPG-R-MRI: UPN: (B)(4), MODEL: DB-1200-S, SERIAL: (B)(4), BATCH: 741696. PRODUCT FAMILY: DBS-EXTENSION: UPN: (B)(4), MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7071084. PRODUCT FAMILY: DBS-EXTENSION: UPN: (B)(4), MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7075492. PRODUCT FAMILY: DBS-LEAD FIXATION: UPN: (B)(4), MODEL: DB-4600C, SERIAL: N/A, BATCH: 25361200. PRODUCT FAMILY: DBS-LEAD FIXATION: UPN: (B)(4), MODEL: DB-4600C, SERIAL: N/A, BATCH: 25361200.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT LEAD WAS EXPOSED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE DBS SYSTEM. IT WAS REPORTED THAT PATIENT WOULD BE ADMITTED INTO THE HOSPITAL FOR A COUPLE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59880 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 5137286 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention