BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 9892323 · Received March 27, 2020

    Report

    Report Number
    3006630150-2020-01498
    Event Type
    Injury
    Date Received
    March 27, 2020
    Date of Event
    February 28, 2020
    Report Date
    March 27, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905271
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: VERCISE CARTESIA, UPN: (B)(4), MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: 7070031.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE DAYS POST IMPLANT THE PATIENT DEVELOPED A SUBCORTICAL HEMATOMA WHICH WAS MODERATE IN SEVERITY. THE PATIENT ALSO EXPERIENCED A SEIZURE WHICH WAS MODERATE IN SEVERITY. THE PATIENT WAS WALKING AND LOSS CONSCIOUSNESS, AND AN EPILEPTIC EPISODE WITH SPASM OF THE EXTREMITY. THE PATIENT WAS ADMITTED INTO THE INTENSIVE CARE UNIT FOR OBSERVATION AND GIVEN MEDICATION. THE PATIENT WAS TRANSFERRED GENERAL FLOOR THE FOLLOWING DAY. IT WAS LATER NOTED THAT THE PATIENTS REGULAR ANTIEPILEPTIC MEDICATION HAD RUN OUT AND HAS NOT BEEN ON MEDICATION FOR DAYS AND THAT THIS MAY HAVE ALSO BEEN THE SOURCE OF THE SEIZURE. A CAT SCAN WAS PERFORMED WHICH SHOWED 1 TO 2 CM HEMATOMA AT THE RIGHT ELECTRODE WHICH CAUSED A SEIZURE. A FOLLOW UP CAT SCAN WAS DONE AND CONFIRMED THAT THE HEMATOMA RESOLVED. THIS EVENT WAS REPORTED AS PROBABLY RELATED TO PROCEDURE AND NOT RELATED TO THE DEVICE OR STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354152 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-30 7070032 08714729905271

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R