BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 15793759 · Received November 14, 2022

    Report

    Report Number
    3006630150-2022-06219
    Event Type
    Injury
    Date Received
    November 14, 2022
    Date of Event
    August 1, 2022
    Report Date
    December 8, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: VERCISE CARTESIA, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR IN BLOCK B3: APPROXIMATED DATE SHOULD HAVE BEEN AUGUST 1, 2022 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: VERCISE CARTESIA, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(6), BATCH: 7071266.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) CLINICAL STUDY PATIENT DEVELOPED WORSENING NEURO-COGNITIVE IMPAIRMENT DUE TO A PERI-LEAD EDEMATOUS, GLIOTIC REACTION. THIS SEVERE EVENT WAS ASSESSED TO BE RELATED TO THE PROCEDURE AND LEADS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND ADMINISTERED MEDICATION. THE PATIENT WAS DISCHARGED AND THE EVENT WAS RESOLVING. THE DEVICES REMAIN IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) CLINICAL STUDY PATIENT DEVELOPED WORSENING NEURO-COGNITIVE IMPAIRMENT DUE TO A PERI-LEAD EDEMATOUS, GLIOTIC REACTION. THIS SEVERE EVENT WAS ASSESSED TO BE RELATED TO THE DEVICE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND ADMINISTERED MEDICATION. THE EVENT WAS RESOLVING. THE DEVICE REMAINS IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED THAT UPON HOSPITAL ADMISSION, THE PATIENT WAS TEMPORARILY DISORIENTED, PARTIALLY APRAXIC WITH BRADYKINESIA OF UPPER AND LOWER EXTREMITIES ON THE RIGHT SIDE AND A BROAD-BASED, SHORT-STEPPED GAIT PATTERN. THE PATIENT WAS TREATED WITH CORTISONE. A HEAD CT WAS PERFORMED WHICH SHOWED NO CLEAR INFLAMMATORY REACTION AND AN EEG SHOWED MODERATE DIFFUSE CEREBRAL DYSFUNCTION. APPROXIMATELY ONE MONTH LATER, THE PATIENT WAS READMITTED TO THE HOSPITAL WHERE THE PATIENT UNDERWENT ANESTHETIZED MAGNETIC RESONANCE IMAGING. THE RESULTS REVEALED INCREASING BILATERAL EDEMA, GLIOSIS IN THE AREA OF THE DBS LEADS FRONTALLY ON BOTH SIDES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS NOTED TO HAVE SLIGHT IMPROVEMENT IN COGNITION, MOBILITY, AND COORDINATION SINCE START OF CORTISONE THERAPY. THE EVENT WAS ASSESSED TO BE DUE TO THE PROCEDURE AND DEVICE HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2773798 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7073540 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other| R| H