BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 15353495 · Received September 3, 2022

    Report

    Report Number
    3006630150-2022-04512
    Event Type
    Injury
    Date Received
    September 3, 2022
    Date of Event
    August 5, 2022
    Report Date
    March 9, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: M365DB220330C0. MODEL: DB-2203-30C. SERIAL: (B)(6). BATCH: 5000410.

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER PHONE: (B)(6). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB220330C0, MODEL: DB-2203-30C, SERIAL: (B)(6), BATCH: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT (A4092 CARTESIA EXTEND 3D STUDY) EXPERIENCED A SERIOUS ADVERSE EVENT OF ACUTE CHANGE OF NATURE, PSYCHOMOTOR AGITATION, AND HYPERKINESIA WHICH WAS DUE TO ACCIDENTAL CHANGE IN DBS PROGRAM, WITH MODERATE SEVERITY. THE PATIENT WAS ADMITTED TO THE HOSPITAL, MEDICATION WAS GIVEN AND THE DEVICE WAS REPROGRAMMED. STIMULATION WAS RETURNED TO THE ORIGINAL PROGRAM WHICH SHOWED SIGNIFICANT IMPROVEMENT OF PSYCHOMOTOR AGITATION, THE STIMULAITON WAS REDUCED TO ADDRESS THE HYPERKINESIA. THE PATIENT SHOWED CLINICAL IMPROVEMENT AND WAS DISCHARGED THREE DAYS LATER. THE EVENT RELATIONSHIP TO PROCEDURE AND STIMULATION WERE REPORTED AS POSSIBLE. THE EVENT RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT (A4092 CARTESIA EXTEND 3D STUDY) EXPERIENCED A SERIOUS ADVERSE EVENT OF ACUTE CHANGE OF NATURE, PSYCHOMOTOR AGITATION, AND HYPERKINESIA WHICH WAS DUE TO ACCIDENTAL CHANGE IN DBS PROGRAM, WITH MODERATE SEVERITY. THE PATIENT WAS ADMITTED TO THE HOSPITAL, MEDICATION WAS GIVEN AND THE DEVICE WAS REPROGRAMMED. STIMULATION WAS RETURNED TO THE ORIGINAL PROGRAM WHICH SHOWED SIGNIFICANT IMPROVEMENT OF PSYCHOMOTOR AGITATION, THE STIMULATION WAS REDUCED TO ADDRESS THE HYPERKINESIA. THE PATIENT SHOWED CLINICAL IMPROVEMENT AND WAS DISCHARGED THREE DAYS LATER. THE EVENT RELATIONSHIP TO PROCEDURE AND STIMULATION WERE REPORTED AS POSSIBLE. THE EVENT RESOLVED. ADDITIONAL INFORMATION WAS PROVIDED THAT THE EVENT WAS NOT RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2447921 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2203-30C 5000410

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention| H