BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECOIN PERIPHERAL NUEROSTIMULATOR

    MDR report key: 17430800 · Received July 31, 2023

    Report

    Report Number
    3010878085-2023-00006
    Event Type
    Injury
    Date Received
    July 31, 2023
    Date of Event
    June 5, 2023
    Report Date
    July 31, 2023
    Manufacturer
    VALENCIA TECHNOLOGIES
    Product Code
    QPT
    UDI-DI
    00860007896903
    PMA / PMN Number
    P200036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    76 YEAR OLD FEMALE IMPLANTED ON (B)(6) 2023. THEY WERE SEEN AT THEIR 4 WEEK ACTIVATION APPOINTMENT WITH NO ISSUES RELATED TO HEALING OR THE INFECTION. ON (B)(6) 2023, THEY WERE SEEN BY THE IMPLANTING PHYSICIAN'S PA. AT THIS APPOINTMENT, AN INFECTION OF THE INCISION SITE WAS NOTED BY THE PA. THE PATIENT WAS PRESCRIBED ANTIBIOTICS (I.E. IM ROCEPHIN, CEFTIN, AND FLAGYL). ON (B)(6) 2023, PATIENT RETURNED TO THE OFFICE FOR A FOLLOW-UP APPOINTMENT AND THE WOUND WAS HEALED. ON (B)(6) 2023, AT A RE-PROGRAMMING APPOINTMENT, VTC SALES PERSONNEL WAS INFORMED OF THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1721795 ECOIN PERIPHERAL NUEROSTIMULATOR ECOIN QPT VALENCIA TECHNOLOGIES 00860007896903

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention