BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 18112807 · Received November 10, 2023

    Report

    Report Number
    3006630150-2023-06942
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    August 19, 2021
    Report Date
    November 10, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    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: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7081903.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED SIDE EFFECTS IN THE EYE WHEN STIMULATION WAS ON CAUSING BURNING SENSATIONS. THE PHYSICIAN ATTEMPTED TO TRY TWO DIFFERENT PROGRAMS TO ADDRESS THE EYE BURNING. ONE WHERE THE PATIENT HAD MORE SEVERE TREMOR BUT BETTER EFFECT ON THE EYE BURNING, AND ANOTHER WHERE THE TREMOR WAS BETTER BUT THE EYE BURNING WOULD OCCUR. MRI IMAGING WAS PERFORMED AND REVEALED THE LEADS WERE SUB-OPTIMALLY PLACED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED LEADS WERE RETAINED BY THE HOSPITAL AND WERE NOT RETURNED TO BSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833412 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7081899 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention