BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECOIN PERIPHERAL NEUROSTIMULATOR

    MDR report key: 24539267 · Received March 6, 2026

    Report

    Report Number
    3010878085-2026-00004
    Event Type
    Injury
    Date Received
    March 6, 2026
    Date of Event
    September 2, 2025
    Report Date
    March 6, 2026
    Manufacturer
    VALENCIA TECHNOLOGIES CORPORATION
    Product Code
    QPT
    UDI-DI
    00860007896903
    PMA / PMN Number
    P200036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY FILE FOR BOTH THE ECOIN DEVICE (502583) INCLUDING THE STERILE LOAD HISTORY REPORT (B)(4) AND THE PROCEDURAL KIT LOT: (300-875) 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 CAUSE OF THE INFECTION IS UNKNOWN. THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ON THE CAUSE OF THE REPORTED ISSUE. THEREFORE, THE ROOT CAUSE CODE WAS SELECTED AS INFECTION- INDETERMINATE ORIGIN.

    Description of Event or Problem · 0

    THE CLINICAL STUDY PATIENT WAS IMPLANTED WITH THE ECOIN DEVICE ON (B)(6) 2025, WITH NO ISSUES REPORTED. THE PATIENT WAS PRESCRIBED PROPHYLACTIC ANTIBIOTICS FROM ON (B)(6) 2025. ON (B)(6) 2025, A WOUND INFECTION WAS REPORTED AT THE INCISION SITE. ADDITIONAL ANTIBIOTICS WERE PRESCRIBED FROM ON (B)(6) 2025 AND THE INFECTION RESOLVED. THE DEVICE WAS ACTIVATED ON (B)(6) 2025 WITH AN AMPLITUDE SETTING OF 4 MA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490900 ECOIN PERIPHERAL NEUROSTIMULATOR ECOIN UUI QPT VALENCIA TECHNOLOGIES CORPORATION 00860007896903

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention