BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECOIN PERIPHERAL NEUROSTIMULATOR

    MDR report key: 24912657 · Received April 17, 2026

    Report

    Report Number
    3010878085-2026-00007
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    March 5, 2026
    Report Date
    May 8, 2026
    Manufacturer
    VALENCIA TECHNOLOGIES CORPORATION
    Product Code
    QPT
    UDI-DI
    00860007896903
    PMA / PMN Number
    P200036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE ASSOCIATED WITH THE COMPLAINT WAS RETURNED. FAILURE ANALYSIS WAS NOT REQUIRED FOR THIS COMPLAINT AS THE DEVICE WAS NEVER ACTIVATED AND THE REPORT OF PAIN WAS NOT RELATED TO STIMULATION. THE ECOIN DEVICE WILL BE DECONTAMINATED AND STORED FOR FUTURE REFERENCE. THE DEVICE HISTORY FILE FOR BOTH THE ECOIN DEVICE (B)(6) INCLUDING THE STERILE LOAD HISTORY REPORT ((B)(4)) AND THE PROCEDURAL KIT LOT (301-707) AVAILABLE AT THE IMPLANTATION FACILITY WERE REVIEWED AND THERE WERE NO RELATED ISSUES FOUND. BASED ON THE INFORMATION PROVIDED, THE PATIENT DID NOT FOLLOW POST-OPERATIVE INSTRUCTIONS AS THEY REMOVED THEIR COMPRESSION SLEEVE AND TEGADERM THE DAY AFTER THE IMPLANT PROCEDURE. ADDITIONALLY, THE PATIENT USED HYDROGEN PEROXIDE ON THE INCISION TWICE DAILY (MORNING AND EVENING) WHILE LEAVING THE SITE UNCOVERED. THE TERRITORY MANAGER REVIEWED ECOIN AFTERCARE INSTRUCTIONS WITH THE PATIENT PRE-OPERATIVELY AND AGAIN POST-OPERATIVELY. PER AFTERCARE INSTRUCTIONS FOR UUI, 903-1145 REV 5., "ANKLE SUPPORT: YOU SHOULD USE THE ANKLE SUPPORT UNTIL THE FIRST POST-PROCEDURE CLINIC VISIT, AND POSSIBLY LONGER, PER SURGEON'S DISCRETION." ADDITIONALLY, "CHANGING THE BANDAGE: YOUR WOUND WAS DRESSED IMMEDIATELY AFTER IMPLANTATION. YOU SHOULD LEAVE THIS DRESSING ON FOR 5-7 DAYS... YOU SHOULD USE CARE TO KEEP THE INCISION SITE DRY FOR THE FIRST TWO WEEKS (UNTIL YOUR HEALING CHECK VISIT) AFTER IMPLANTATION." THE ECOIN DEVICE IS USED TO TREAT URGENCY URINARY INCONTINENCE. THE CAUSE OF THE ANKLE AND FOOT DISCOMFORT WAS DUE TO DEHISCENCE. HOWEVER, THE CAUSE OF THE DEHISCENCE IS DUE TO PATIENT NON-COMPLIANCE AS THE PATIENT DID NOT FOLLOW POST-OPERATIVE INSTRUCTIONS.

    Description of Event or Problem · 0

    THE PATIENT WAS IMPLANTED WITH THE ECOIN DEVICE ON (B)(6) 2026. THE DEVICE WAS SCHEDULED TO BE ACTIVATED ON (B)(6) 2026. HOWEVER, THE PATIENT REPORTED PAIN (ANKLE AND FOOT DISCOMFORT) TO TERRITORY MANAGER, (B)(6) AS WELL AS THE IMPLANTING PHYSICIAN. THE PATIENT WAS EXAMINED BY THE IMPLANTING PHYSICIAN FOR INFECTION, DEEP VEIN THROMBOSIS (DVT), AND HEMATOMA. ALTHOUGH ALL RESULTS WERE NEGATIVE AND THERE WERE NO SIGNS OF INFECTION, ANTIBIOTICS WERE PRESCRIBED AND THE DEVICE WAS NOT ACTIVATED IN ORDER TO FOCUS ON WOUND CARE DUE TO DEHISCENCE. THE PATIENT ATTENDED FOLLOW-UP APPOINTMENTS WITH THE IMPLANTING PHYSICIAN ON (B)(6) 2026 AND (B)(6) 2026 AS WELL AS BEING SEEN BY URGENT CARE AND THE EMERGENCY ROOM. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2026. THERE WERE NO SIGNS OF INFECTION LEADING UP TO OR FOLLOWING THE EXPLANT PROCEDURE. AFTER THE EXPLANT PROCEDURE, THE PATIENT RETURNED TO THE EMERGENCY ROOM AFTER REMOVING THE DRESSING, EXPOSING THE SITE TO WATER, AND CONTINUING HYDROGEN PEROXIDE USE. THE PATIENT ATTENDED ANOTHER FOLLOW-UP APPOINTMENT ON (B)(6) 2026 AND WAS REFERRED TO WOUND CARE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459667 ECOIN PERIPHERAL NEUROSTIMULATOR ECOIN UUI QPT VALENCIA TECHNOLOGIES CORPORATION 00860007896903

    Patients

    Seq Age Sex Outcome Treatment
    1