BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 16717618 · Received April 11, 2023

    Report

    Report Number
    3006630150-2023-01932
    Event Type
    Injury
    Date Received
    April 11, 2023
    Date of Event
    June 8, 2022
    Report Date
    April 11, 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
    TX, 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)(4); BATCH: 7091363.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. REPROGRAMMING WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THE SURGEON ASSESSED THE LEADS WERE NOT PLACED IN THE CORRECT TARGET POSITION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED LEADS WERE DISPOSED OF AT THE FACILITY AND WERE NOT RETURNED TO BSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424857 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7091365 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Required Intervention