BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 16999477 · Received May 24, 2023

    Report

    Report Number
    3006630150-2023-02942
    Event Type
    Injury
    Date Received
    May 24, 2023
    Date of Event
    April 19, 2023
    Report Date
    May 24, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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: 7102394.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SEIZURE FOLLOWING A DEEP BRAIN STIMULATION (DBS) LEAD PLACEMENT PROCEDURE. THE CAUSE IS UNKNOWN AND IS NOT KNOWN TO BE DEVICE-RELATED. HOWEVER, THE PHYSICIAN ASSESSED THE EVENT AS PROCEDURE-RELATED. IT WAS ALSO NOTED THAT SUBSEQUENT MRIS (MAGNETIC RESONANCE IMAGING) WILL BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506631 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7102317 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other