BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECOIN PERIPHERAL NEUROSTIMULATOR

    MDR report key: 24772142 · Received April 2, 2026

    Report

    Report Number
    3010878085-2026-00005
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    March 5, 2026
    Report Date
    April 2, 2026
    Manufacturer
    VALENCIA TECHNOLOGIES CORPORATION
    Product Code
    QPT
    UDI-DI
    00860007896903
    PMA / PMN Number
    P200036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 (301-151) AND THE PROCEDURAL KIT LOT (301-705) AVAILABLE AT THE IMPLANTATION FACILITY WERE REVIEWED AND THERE WERE NO RELATED ISSUES FOUND. BASED ON THE INFORMATION PROVIDED, THE PATIENT MAY HAVE BEEN PICKING AT THE WOUND WHICH CAUSED THE ORIGINAL OPENING/DISCOMFORT. THE EXPLANTED ECOIN DEVICE ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED AND COULD NOT BE ANALYZED. VALENCIA TECHNOLOGIES WAS UNABLE TO CONFIRM THE REPORT OF THE DEVICE PROVIDING STIMULATION AFTER BEING PUT IN SHELF MODE. THE ECOIN DEVICE IS USED TO TREAT URGENCY URINARY INCONTINENCE. THE CAUSE OF THE REPORTED ISSUE 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 INDETERMINATE ORIGIN.

    Description of Event or Problem · 0

    THE PATIENT WAS IMPLANTED WITH THE ECOIN DEVICE ON (B)(6), 2026 AND THE DEVICE WAS ACTIVATED ON (B)(6) 2026 WITH AN AMPLITUDE SETTING OF 3 MA. ON MARCH 05, 2026, TERRITORY MANAGER, (B)(6), RECEIVED A PHONE CALL FROM THE PATIENT REGARDING AN INFECTION AT THE INCISION SITE AND ANTIBIOTICS WERE PRESCRIBED BY THE IMPLANTING PHYSICIAN. THE PATIENT DESCRIBED THE INFECTION AS AN ALLERGY TO THE SUTURING. HOWEVER, THIS WAS NOT CONFIRMED BY MEDICAL PROFESSIONALS. CULTURES OF THE WOUND WERE OBTAINED, AND THE RESULTS CAME BACK NEGATIVE, INDICATING THAT NO INFECTION WAS PRESENT. ADDITIONALLY, APPROXIMATELY ONE WEEK BEFORE THE PHONE CALL, THE PATIENT REPORTEDLY EXPERIENCED SHOOTING PAIN IN THE BOTTOM OF THEIR FOOT AND UP THEIR LEG. THE PATIENT DID NOT REPORT ANY PAIN WHEN THE DEVICE WAS INITIALLY ACTIVATED ALTHOUGH THEY WERE VERY SENSITIVE TO THE STIMULATION. ON MARCH 06, 2026, THE TERRITORY MANAGER MET WITH THE PATIENT AND TURNED THE DEVICE OFF BY PLACING IT IN SHELF MODE. ADDITIONALLY, THE PATIENT SAW A NURSE AND RECEIVED ADVICE ON THEIR WOUND. ON MARCH 11, 2026, THE PATIENT REPORTED THEIR ECOIN DEVICE WENT OFF AT 12:30PM DESPITE THE DEVICE BEING PUT IN SHELF MODE ON MARCH 06, 2026. THE PATIENT MET WITH THE IMPLANTING PHYSICIAN ON (B)(6) 2026 TO DISCUSS DEVICE REMOVAL. THE DEVICE WAS EXPLANTED ON (B)(6) 2026 AND THE PATIENT HAS NOT EXPERIENCED ANY ADDITIONAL PAIN. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829659 ECOIN PERIPHERAL NEUROSTIMULATOR ECOIN UUI QPT VALENCIA TECHNOLOGIES CORPORATION 00860007896903

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention