BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECOIN PERIPHERAL NEUROSTIMULATOR

    MDR report key: 24918586 · Received April 17, 2026

    Report

    Report Number
    3010878085-2026-00008
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    July 15, 2024
    Report Date
    April 17, 2026
    Manufacturer
    VALENCIA TECHNOLOGIES CORPORATION
    Product Code
    QPT
    UDI-DI
    00860007896903
    PMA / PMN Number
    P200036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY FILE FOR BOTH THE ECOIN DEVICE (B)(6) INCLUDING THE STERILE LOAD HISTORY REPORT (300-677) AND THE PROCEDURAL KIT LOT (300-755) AVAILABLE AT THE IMPLANTATION FACILITY WERE REVIEWED AND THERE WERE NO RELATED ISSUES FOUND. THE ECOIN DEVICE IS USED TO TREAT URGENCY URINARY INCONTINENCE. THE REDNESS WAS RESOLVED AND THE INCISION SITE WAS HEALING AS EXPECTED.

    Description of Event or Problem · 0

    THE PATIENT WAS IMPLANTED WITH THE ECOIN DEVICE ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT REPORTED MILD REDNESS AT THE INCISION SITE AND ANTIBIOTICS WERE PRESCRIBED. THE REDNESS RESOLVED BY (B)(6) 2024 AND THERE WAS NO LASTING IMPAIRMENT TO WOUND HEALING OR DELAYS TO ACTIVATION WHICH OCCURRED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976871 ECOIN PERIPHERAL NEUROSTIMULATOR ECOIN UUI QPT VALENCIA TECHNOLOGIES CORPORATION 00860007896903

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention