BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 18882019 · Received March 11, 2024

    Report

    Report Number
    3006630150-2024-01370
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    August 17, 2022
    Report Date
    March 11, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, BATCH: 29238914; PRODUCT FAMILY: DBS-LINEAR LEADS, UPN:M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7093631.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED TREMOR AND DYSARTHRIA AS A RESULT OF SUBOPTIMAL LEAD PLACEMENT. THE PATIENT UNDERWENT A REVISION WHEREIN ONE LEAD WAS REPOSITIONED, AND A SECOND LEAD AND BURR HOLE COVER WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2450986 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7091647 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention