BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECOIN PERIPHERAL NEUROSTIMULATOR

    MDR report key: 24306487 · Received February 10, 2026

    Report

    Report Number
    3010878085-2026-00003
    Event Type
    Injury
    Date Received
    February 10, 2026
    Date of Event
    January 12, 2026
    Report Date
    February 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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE PATIENT DID NOT FEEL EXCESSIVE OR SEVERE PAIN AT OR NEAR IMPLANT SITE. THERE WAS NO EVIDENCE OF ANY CO-MORBIDITIES THAT COULD IMPACT HEALING OR INFECTION OCCURRENCE (E.G. DIABETES, IMMUNE DEFICIENCY). THERE WAS NO CONCERN ABOUT PATIENT HYGIENE. THE PATIENT WAS COMPLIANT TO AFTERCARE INSTRUCTIONS AS WELL AS INSTRUCTIONS REGARDING INCISION CARE. THE DEVICE HISTORY FILE FOR BOTH THE ECOIN DEVICE ((B)(6)) INCLUDING THE STERILE LOAD HISTORY REPORT ((B)(4)) AND THE PROCEDURAL KIT LOT (301-355, R00647) 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 PATIENT WAS IMPLANTED WITH THE ECOIN DEVICE ON (B)(6) 2025. ON (B)(6) 2025, THE WOUND WAS CLEARED FOR ACTIVATION WITH NO SIGNS OF INFECTION AT THE TIME AND THE DEVICE WAS ACTIVATED WITH AN AMPLITUDE SETTING OF 6MA. ON (B)(6) 2026, THE TERRITORY MANAGER BECAME AWARE THAT THE PATIENT WAS EXPERIENCING AN INFECTION THAT WAS SLIGHTLY OOZING FROM THE ECOIN INCISION SITE. ADDITIONALLY, THE DEVICE POCKET WAS SLIGHTLY SWOLLEN AND RED. ANTIBIOTICS WERE PRESCRIBED AND THE AREA WAS TOPICALLY CLEANED. AS OF (B)(6) 2026, THE INFECTION HAS CLEARED. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365411 ECOIN PERIPHERAL NEUROSTIMULATOR ECOIN UUI QPT VALENCIA TECHNOLOGIES CORPORATION 00860007896903

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention