BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 16519661 · Received March 10, 2023

    Report

    Report Number
    3006630150-2023-01180
    Event Type
    Injury
    Date Received
    March 10, 2023
    Date of Event
    October 6, 2022
    Report Date
    March 10, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7077059. PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: NOT APPLICABLE, BATCH: 26729878 AND 26793896. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7103295 AND 7103678.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE IN WHICH THE ENTIRE DEEP BRAIN STIMULATION (DBS) SYSTEM WAS EXPLANTED. THE PATIENT STATUS WAS NOT PROVIDED PER THE HOSPITAL CONFIDENTIALITY POLICY. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE DISPOSED OF BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922466 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7076471 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention