BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 19103148 · Received April 14, 2024

    Report

    Report Number
    3006630150-2024-02359
    Event Type
    Injury
    Date Received
    April 14, 2024
    Date of Event
    February 23, 2024
    Report Date
    April 14, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    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)(6), BATCH: 7111005.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT CLAIMED THEY EXPERIENCED PAIN AND FELT EVERYTHING DURING THE STAGE ONE OF THE DEEP BRAIN STIMULATION (DBS) PROCEDURE. THE PATIENT STATED HE WAS ADMINISTERED NOVOCAIN HOWEVER HAD TO CHANGED TO PROPOFOL SINCE HE WAS EXPERIENCING PAIN DURING THE INCISIONS/SURGICAL PROCEDURE. IT WAS NOTED THAT A DRILL BIT BROKE DURING THE SURGERY BY THE PHYSICIANS ASSISTANT AND HAD WAITED APPROXIMATELY FIFTEEN MINUTES TO REPLACE AND RESUME WHERE HE WAS INFORMED THEY DEVIATED FROM INITIAL TARGET BECAUSE AN OBSTRUCTION WAS FOUND THAT WAS NOT REVEALED IN ANY IMAGING. THE PATIENT EXPERIENCED WEAKNESS AND WAS UNABLE TO MOVE RIGHT LEG. IT IS CURRENTLY UNKNOWN IF ANY MEDICAL OR SURGICAL INTERVENTION WAS NEEDED, HOWEVER PATIENT IS DOING FINE NOW. ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470650 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7105469 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention