BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECOIN PERIPHERAL NUEROSTIMULATOR

    MDR report key: 19378181 · Received May 22, 2024

    Report

    Report Number
    3010878085-2024-00007
    Event Type
    Injury
    Date Received
    May 22, 2024
    Date of Event
    April 25, 2024
    Report Date
    May 22, 2024
    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

    83 YEAR OLD FEMALE IMPLANTED ON (B)(6) 2024. AT ACTIVATION APPOINTMENT ON (B)(6) 2024 PRESENTED WITH AN INFECTION AT THE INCISION SITE. ACTIVATION WAS DELAYED DUE TO INFECTION AND PATIENT WAS REFERRED TO A WOUND CARE CLINIC. PREVIOUSLY, AT 2-WEEK HEALING CHECK, PATIENT HAD "SOME REDNESS" AND WAS PRESCRIBED ANTIBIOTICS. VTC WAS NOT AWARE UNTIL 04/25/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559577 ECOIN PERIPHERAL NUEROSTIMULATOR ECOIN UUI QPT VALENCIA TECHNOLOGIES 00860007896903

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention