BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECOIN PERIPHERAL NEUROSTIMULATOR

    MDR report key: 22591432 · Received July 24, 2025

    Report

    Report Number
    3010878085-2025-00003
    Event Type
    Injury
    Date Received
    July 24, 2025
    Date of Event
    March 26, 2025
    Report Date
    July 24, 2025
    Manufacturer
    VALENCIA TECHNOLOGIES CORPORATION
    Product Code
    QPT
    UDI-DI
    00860007896903
    PMA / PMN Number
    P200036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY FILE FOR BOTH THE ECOIN DEVICE (501774) INCLUDING THE STERILE LOAD HISTORY REPORT (249-602) AND THE PROCEDURAL KIT LOT (300-688) AVAILABLE AT THE IMPLANTATION FACILITY WERE REVIEWED AND THERE WERE NO RELATED ISSUES FOUND. THE DEVICE ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. THE DEVICE PASSED ALL ELECTRICAL TESTS. BASED ON THE INFORMATION PROVIDED, THE PATIENT HAS RHEUMATOID ARTHRITIS AS WELL AS PERIPHERAL VASCULAR DISEASE IN THEIR LOWER LEGS. PER ECOIN PHYSICIAN MANUAL (903-1225 REV. V5), UNDER CONTRAINDICATIONS "POOR SURGICAL CANDIDATES: THE ECOIN SHOULD NOT BE IMPLANTED IN PATIENTS WHO ARE POOR SURGICAL CANDIDATES. POOR SURGICAL CANDIDATES INCLUDE THOSE WHO HAVE: VENOUS DISEASE/INSUFFICIENCY IN THE LOWER LEG." THE ECOIN DEVICE IS USED TO TREAT URGENCY URINARY INCONTINENCE. THE CAUSE OF THE IMPAIRED HEALING IS DUE TO PATIENT SELECTION AS THE PATIENT IS A POOR SURGICAL CANDIDATE.

    Description of Event or Problem · 0

    THE PATIENT REPORTED IMPAIRED WOUND HEALING AT THE INCISION SITE AS WELL AS EXPOSURE OF THE ECOIN DEVICE. THE WOUND WAS TREATED, SEVERAL ROUNDS OF ANTIBIOTICS WERE PRESCRIBED, AND THE PATIENT WAS REFERRED TO WOUND CARE. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2025, THE WOUND WAS IRRIGATED, AND SUTURES WERE PLACED. THE PATIENT ATTENDED A POST-OPERATIVE APPOINTMENT AFTER THE EXPLANT PROCEDURE WHERE THE SUTURES WERE REMOVED AND IT WAS NOTED THE WOUND WAS HEALING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859608 ECOIN PERIPHERAL NEUROSTIMULATOR ECOIN UUI QPT VALENCIA TECHNOLOGIES CORPORATION 00860007896903

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention