BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECOIN PERIPHERAL NUEROSTIMULATOR

    MDR report key: 19591091 · Received June 22, 2024

    Report

    Report Number
    3010878085-2024-00009
    Event Type
    Injury
    Date Received
    June 22, 2024
    Date of Event
    May 16, 2024
    Report Date
    June 22, 2024
    Manufacturer
    VALENCIA TECHNOLOGIES CORP
    Product Code
    QPT
    UDI-DI
    0086000789603
    PMA / PMN Number
    P200036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    56-YEAR-OLD MALE IMPLANTED ON (B)(6) 2024. AT ACTIVATION APPOINTMENT ON (B)(6) 2024, PATIENT PRESENTED WITH SUPERFICIAL IRRITATION AND POSSIBLE INFECTION. PATIENT REPORTED THE ISSUE BEGAN A WEEK PRIOR. PATIENT WAS PRESCRIBED A BROAD-SPECTRUM ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019500 ECOIN PERIPHERAL NUEROSTIMULATOR ECOIN UUI QPT VALENCIA TECHNOLOGIES CORP 0086000789603

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention