BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECOIN PERIPHERAL NUEROSTIMULATOR

    MDR report key: 18754371 · Received February 21, 2024

    Report

    Report Number
    3010878085-2024-00003
    Event Type
    Injury
    Date Received
    February 21, 2024
    Date of Event
    January 25, 2024
    Report Date
    February 20, 2024
    Manufacturer
    VALENCIA TECHNOLOGIES
    Product Code
    QPT
    PMA / PMN Number
    P200036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    76 YEAR OLD FEMALE IMPLANTED ON (B)(6) 2023. ON (B)(6) 2024, PATIENT PRESENTED WITH AN INFECTION AT THE INCISION SITE. PATIENT WAS PRESCRIBED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416020 ECOIN PERIPHERAL NUEROSTIMULATOR ECOIN UUI QPT VALENCIA TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention