BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECOIN PERIPHERAL NEUROSTIMULATOR

    MDR report key: 24841184 · Received April 10, 2026

    Report

    Report Number
    3010878085-2026-00006
    Event Type
    Injury
    Date Received
    April 10, 2026
    Date of Event
    February 7, 2026
    Report Date
    April 10, 2026
    Manufacturer
    VALENCIA TECHNOLOGIES CORPORATION
    Product Code
    QPT
    UDI-DI
    00860007896903
    PMA / PMN Number
    P200036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE PATIENT HAS BILATERAL LEG AND FOOT NEUROPATHY WITH REDUCED SENSATION IN THEIR FEET. DUE TO THE PATIENT'S POOR SENSATION OF THEIR FEET, THEY DID NOT NOTICE THE WOUND ON THEIR TOE WHICH LED TO CELLULITIS AND THE WEAKENING AND OPENING OF THE INCISIONAL SCAR. THE DEVICE HISTORY FILE FOR BOTH THE ECOIN DEVICE (B)(6) INCLUDING THE STERILE LOAD HISTORY REPORT (232-595) AND THE PROCEDURAL KIT LOT (300-458) 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 INVESTIGATION FOUND THAT THE PATIENT'S COMORBIDITY (BILATERAL LEG AND FOOT NEUROPATHY) CONTRIBUTED TO THE REPORT OF CELLULITIS AND INFECTION AND THIS WAS NOT ATTRIBUTED TO THE ECOIN DEVICE.

    Description of Event or Problem · 0

    THE PATIENT WAS IMPLANTED WITH THE ECOIN DEVICE ON (B)(6), 2024 AND THE DEVICE WAS ACTIVATED ON (B)(6), 2024 WITH AN AMPLITUDE SETTING OF 8 MA. ALTHOUGH THE PATIENT WAS RESPONDING POSITIVELY TO ECOIN THERAPY, THE PATIENT STEPPED ON A PIECE OF ICE AND DEVELOPED A TOE WOUND IN(B)(6) 2026 THAT REQUIRED MEDICAL CARE FROM A PODIATRIST AS WELL AS A WOUND CARE CLINIC. AFTER RECEIVING MEDICAL CARE, THE PATIENT'S WOUND TURNED INTO CELLULITIS AND AN INFECTION OF THEIR FOOT AND LEG. THE PATIENT WAS ALSO SEEN BY INFECTIOUS DISEASE WHO TREATED THE CELLULITIS AND PRESCRIBED ORAL ANTIBIOTICS. SUBSEQUENTLY, THE SCAR FROM THE ECOIN IMPLANT OPENED AND BECAME A SUPERFICIAL WOUND. THE PATIENT WAS HOSPITALIZED DUE TO RIGHT LEG CELLULITIS ON (B)(6), 2026 AND I.V. ANTIBIOTICS WERE PRESCRIBED. THE PATIENT WAS DISCHARGED ON (B)(6), 2026 AND ADDITIONAL ANTIBIOTICS WERE PRESCRIBED TO TAKE AT HOME. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6), 2026 AS THE PATIENT HAD UNDERGONE TREATMENT FOR MANY WEEKS WITHOUT SIGNIFICANT IMPROVEMENT. APPROXIMATELY ONE WEEK AFTER THE EXPLANT, A WOUND VACUUM-ASSISTED CLOSURE (VAC) WAS PERFORMED ON THE INCISION AREA CREATED BY THE EXPLANT. AS OF (B)(6), 2026, THE INFECTION AND CELLULITIS HAVE NOT COMPLETELY RESOLVED. HOWEVER, THEY ARE SLOWLY IMPROVING UNDER THE CARE OF A WOUND CARE NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902124 ECOIN PERIPHERAL NEUROSTIMULATOR ECOIN UUI QPT VALENCIA TECHNOLOGIES CORPORATION 00860007896903

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Hospitalization| R