BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 18882733 · Received March 11, 2024

    Report

    Report Number
    3006630150-2024-01375
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    March 1, 2024
    Report Date
    June 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: 7113712.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE INITIAL IMPLANT PROCEDURE AFTER STAGE ONE LEADS WERE IMPLANTED AND THE SCALP CLOSED THE PATIENT WAS GIVEN GENERAL ANESTHESIA PRIOR STAGE TWO OF THE PROCEDURE. THE PATIENTS VITAL SIGNS QUICKLY DETERIORATED, AND THE ANESTHETIST DETERMINED THE PATIENT WAS EXPERIENCING AN ANAPHYLACTIC REACTION TO THE ANESTHESIA. CARDIOPULMONARY RESUSCITATION (CPR) WAS REQUIRED AND CONTINUED FOR AN HOUR; ATTEMPTS TO DEFIBRILLATE OCCURRED, AND EVENTUALLY CARDIAC RHYTHM WAS RE-ESTABLISHED. AN ADDITIONAL ARTERIAL LINE WAS INSERTED, AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS STARTED. THE PATIENT WAS PROVIDED MEDICATION, STABILIZED, AND TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT WAS SUCCESSFULLY TAKEN OFF ECMO AND IS RECOVERING WELL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE INITIAL IMPLANT PROCEDURE AFTER STAGE ONE LEADS WERE IMPLANTED AND THE SCALP CLOSED THE PATIENT WAS GIVEN GENERAL ANESTHESIA PRIOR STAGE TWO OF THE PROCEDURE. THE PATIENTS VITAL SIGNS QUICKLY DETERIORATED, AND THE ANESTHETIST DETERMINED THE PATIENT WAS EXPERIENCING AN ANAPHYLACTIC REACTION TO THE ANESTHESIA. CARDIOPULMONARY RESUSCITATION (CPR) WAS REQUIRED AND CONTINUED FOR AN HOUR; ATTEMPTS TO DEFIBRILLATE OCCURRED, AND EVENTUALLY CARDIAC RHYTHM WAS RE-ESTABLISHED. AN ADDITIONAL ARTERIAL LINE WAS INSERTED, AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS STARTED. THE PATIENT WAS PROVIDED MEDICATION, STABILIZED, AND TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT WAS SUCCESSFULLY TAKEN OFF ECMO AND IS RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1222215 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7114292 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Hospitalization| R