BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECOIN PERIPHERAL NEUROSTIMULATOR

    MDR report key: 22810063 · Received August 14, 2025

    Report

    Report Number
    3010878085-2025-00004
    Event Type
    Injury
    Date Received
    August 14, 2025
    Date of Event
    July 15, 2025
    Report Date
    August 27, 2025
    Manufacturer
    VALENCIA TECHNOLOGIES CORPORATION
    Product Code
    QPT
    UDI-DI
    00860007896903
    PMA / PMN Number
    P200036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY FILE FOR BOTH THE ECOIN DEVICE (503075) INCLUDING THE STERILE LOAD HISTORY REPORT (300-912) AND THE PROCEDURAL KIT LOT (301-250) AVAILABLE AT THE IMPLANTATION FACILITY WERE REVIEWED AND THERE WERE NO RELATED ISSUES FOUND. POTENTIAL CAUSES OF IMPAIRED HEALING INCLUDE: THE PATIENT HAVING CO-MORBIDITIES, THE PATIENT PARTICIPATING IN ANY UNUSUAL/STRENUOUS ACTIVITY, OR EXPERIENCING ANY TRAUMA AT THE IMPLANT SITE. THE ECOIN DEVICE IS USED TO TREAT URGENCY URINARY INCONTINENCE. THE CAUSE OF THE IMPAIRED HEALING IS UNKNOWN. THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ON THE CAUSE OF THE IMPAIRED HEALING. THEREFORE, THE ROOT CAUSE CODE WAS SELECTED AS UNABLE TO DETERMINE.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY FILE FOR BOTH THE ECOIN DEVICE (503075) INCLUDING THE STERILE LOAD HISTORY REPORT (300-912) AND THE PROCEDURAL KIT LOT (301-250) AVAILABLE AT THE IMPLANTATION FACILITY WERE REVIEWED AND THERE WERE NO RELATED ISSUES FOUND. POTENTIAL CAUSES OF IMPAIRED HEALING INCLUDE: THE PATIENT HAVING CO-MORBIDITIES, THE PATIENT PARTICIPATING IN ANY UNUSUAL/STRENUOUS ACTIVITY, OR EXPERIENCING ANY TRAUMA AT THE IMPLANT SITE. HOWEVER, THE PATIENT DID NOT REPORT ANY UNUSUAL ACTIVITY OR TRAUMA. THE ECOIN DEVICE IS USED TO TREAT URGENCY URINARY INCONTINENCE. THE CAUSE OF THE IMPAIRED HEALING IS UNKNOWN. THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ON THE CAUSE OF THE IMPAIRED HEALING. THEREFORE, THE ROOT CAUSE CODE WAS SELECTED AS UNABLE TO DETERMINE.

    Description of Event or Problem · 0

    THE PATIENT WAS IMPLANTED WITH THE ECOIN DEVICE ON (B)(6) 2025. HOWEVER, THE DEVICE WAS NEVER ACTIVATED AS THE PATIENT MISSED THEIR ACTIVATION APPOINTMENT. ON (B)(6) 2025, THE PATIENT REPORTED THEIR INCISION SITE WAS NOT HEALING AND THEY HAD BEEN SEEING WOUND CARE AT THEIR PRIMARY CARE. THE IMPLANTING CLINICIAN AND TERRITORY MANAGER WERE NOT MADE AWARE OF THE DELAYED WOUND HEALING UNTIL (B)(6) 2025. THE PATIENT IS SEEING WOUND CARE FOR DEBRIDEMENT AND WILL FOLLOW-UP WITH UROLOGY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    THE PATIENT WAS IMPLANTED WITH THE ECOIN DEVICE ON (B)(6) 2025. HOWEVER, THE DEVICE WAS NEVER ACTIVATED AS THE PATIENT MISSED THEIR ACTIVATION APPOINTMENT. ON (B)(6) 2025, THE PATIENT REPORTED THEIR INCISION SITE WAS NOT HEALING AND THEY HAD BEEN SEEING WOUND CARE AT THEIR PRIMARY CARE. THE IMPLANTING CLINICIAN AND TERRITORY MANAGER WERE NOT MADE AWARE OF THE DELAYED WOUND HEALING UNTIL (B)(6) 2025. THE PATIENT IS SEEING WOUND CARE FOR DEBRIDEMENT AND WILL FOLLOW-UP WITH UROLOGY. ADDITIONAL INFORMATION WAS PROVIDED ON AUGUST 14, 2025. AN INFECTION WAS CONFIRMED, THE PATIENT IS NO LONGER ON ANTIBIOTICS, AND THE WOUND IS HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866031 ECOIN PERIPHERAL NEUROSTIMULATOR ECOIN UUI QPT VALENCIA TECHNOLOGIES CORPORATION 00860007896903

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention