BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 12110499 · Received July 2, 2021

    Report

    Report Number
    3006630150-2021-03448
    Event Type
    Injury
    Date Received
    July 2, 2021
    Date of Event
    June 7, 2021
    Report Date
    July 2, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT LEFT LEAD EXTENSION: PRODUCT FAMILY DBS-EXTENSION UPN (B)(4). MODEL NM-3138-55 SERIAL (B)(4). BATCH 7082534.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION WITH PURULENT DRAINAGE AT THE LEFT LEAD INCISION SITE. THE PATIENT WAS HOSPITALIZED FOR TWO DAYS AND WAS DISCHARGED WITH A 13-DAY COURSE OF ANTIBIOTICS. IT WAS NOTED THAT NOTHING HAPPENED DURING THE RECENT IMPLANT PROCEDURE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION. THE PHYSICIAN ASSESSED THAT THE INFECTION WAS DEVICE RELATED. THE DEVICES REMAINS IMPLANTED, AND THE PATIENT IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007532 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7078711 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R