BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECOIN PERIPHERAL NEUROSTIMULATOR

    MDR report key: 24043888 · Received January 12, 2026

    Report

    Report Number
    3010878085-2026-00001
    Event Type
    Injury
    Date Received
    January 12, 2026
    Date of Event
    October 20, 2025
    Report Date
    March 20, 2026
    Manufacturer
    VALENCIA TECHNOLOGIES CORPORATION
    Product Code
    QPT
    PMA / PMN Number
    P200036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, DEVICE MIGRATION AND ANY CHANGES IN THE PATIENT'S MEDICAL HISTORY PRIOR TO THE EXPLANT HAVE BEEN RULED AS POTENTIAL CAUSES. THE DEVICE HISTORY FILE FOR BOTH THE ECOIN DEVICE (503250) INCLUDING THE STERILE LOAD HISTORY REPORT (300-974) AND THE PROCEDURAL KIT LOT (301-355, R00647) 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 AND NO DEVICE RELATED ISSUES WERE FOUND. THE ECOIN DEVICE IS USED TO TREAT URGENCY URINARY INCONTINENCE. ALTHOUGH THE CAUSE OF THE REPORTED ISSUE IS UNKNOWN, THERE WAS NO CONFIRMED DEVICE FAILURE.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY FILE FOR BOTH THE ECOIN DEVICE (B)(6) INCLUDING THE STERILE LOAD HISTORY REPORT (300-974) AND THE PROCEDURAL KIT LOT (301-355, R00647) AVAILABLE AT THE IMPLANTATION FACILITY WERE REVIEWED AND THERE WERE NO RELATED ISSUES FOUND. THE DEVICE ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. HOWEVER, FAILURE ANALYSIS INVESTIGATION HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 0

    THE PATIENT WAS IMPLANTED WITH THE ECOIN DEVICE ON (B)(6) 2025 AND THE DEVICE WAS ACTIVATED ON (B)(6) 2025 WITH AN AMPLITUDE SETTING OF 8MA. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2025 DUE TO AN INFECTION AT THE INCISION SITE. ADDITIONALLY, THE PATIENT WAS NOT GETTING ANY URINARY SYMPTOM RELIEF. ANTIBIOTICS WERE PRESCRIBED AND THE INFECTION HAS BEEN RESOLVED.

    Description of Event or Problem · 0

    THE PATIENT WAS IMPLANTED WITH THE ECOIN DEVICE ON (B)(6) 2025 AND THE DEVICE WAS ACTIVATED ON (B)(6) 2025 WITH AN AMPLITUDE SETTING OF 8MA. ON (B)(6) 2025, THE DEVICE WAS EXPLANTED DUE TO AN INFECTION AT THE INCISION SITE. ADDITIONALLY, THE PATIENT WAS NOT GETTING ANY URINARY SYMPTOM RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106273 ECOIN PERIPHERAL NEUROSTIMULATOR ECOIN UUI QPT VALENCIA TECHNOLOGIES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention