BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 12214590 · Received July 22, 2021

    Report

    Report Number
    3006630150-2021-03993
    Event Type
    Injury
    Date Received
    July 22, 2021
    Date of Event
    July 6, 2021
    Report Date
    July 22, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT. PRODUCT FAMILY DBS-LINEAR LEADS, UPN M365DB2202450, MODEL DB-2202-45, SERIAL (B)(4), BATCH 7082167.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECENTLY IMPLANTED PATIENT EXPERIENCED MILD SUPERFICIAL DRAINAGE AT THE LEFT FRONTAL AND LEFT PARIETAL INCISIONS. THE PATIENT WENT TO THE HOSPITAL AND WAS ADMINISTERED ANTIBIOTICS. IT WAS ASSESSED THAT THE EVENT WAS NOT DEVICE RELATED, AND THE NURSE PRACTITIONER ASSESSED THAT THE EVENT WAS NOT DEVICE RELATED, AND NOTHING HAPPENED DURING THE IMPLANT PROCEDURE THAT MAY HAVE CAUSED OR CONTRIBUTED TO INFECTION. THE PATIENT WAS RELEASED FROM THE HOSPITAL AND THE DEVICES REMAIN IMPLANTED. THERE IS NO FURTHER COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108151 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7081224 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R