BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 18862725 · Received March 7, 2024

    Report

    Report Number
    3006630150-2024-01302
    Event Type
    Injury
    Date Received
    March 7, 2024
    Date of Event
    January 4, 2024
    Report Date
    March 7, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: DB-2202-45, MODEL: M365DB2202450, SERIAL: (B)(6), BATCH: 7113620.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SEIZURE SOMETIME AFTER A DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE. IMAGING TAKEN CONFIRMED AN INTRACRANIAL HEMORRHAGE NEAR THE LEFT DBS LEAD, HOWEVER THE SERIAL NUMBER TO THE LEFT LEAD IS CURRENTLY CONFIRMED. THE PATIENT UNDERWENT A CRANIOTOMY FOR EVACUATION PROCEDURE. THE PATIENT WAS ADMITTED TO REHABILITATION UNTIL (B)(6) 2024. THE PATIENT WAS RELEASED AND DID WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170932 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7112995 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Hospitalization| R