MAUDE Adverse Event Report: VALENCIA TECHNOLOGIES CORPORATION ECOIN PERIPHERAL NEUROSTIMULATOR; ECOIN UUI

Catalog Number	1011-2447
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
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
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.
Event or Problem Description
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.

• Brand Name: ECOIN PERIPHERAL NEUROSTIMULATOR
• Common Device Name: ECOIN UUI
• Manufacturer (Section D): VALENCIA TECHNOLOGIES CORPORATION; 28464 westinghouse pl.; valencia CA 91355
• Manufacturer (Section G): VALENCIA TECHNOLOGIES CORPORATION; 28464 westinghouse pl.; valencia CA 91355
• Manufacturer Contact: alicia pagliaro ; 28464 westinghouse pl.; valencia, CA 91355
• MDR Report Key: 22810063
• Report Number: 3010878085-2025-00004
• Device Sequence Number: 15403243
• Product Code: QPT
• UDI-Device Identifier: 00860007896903
• UDI-Public: (01)00860007896903(11)240604(17)260604
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P200036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/04/2026
• Device Catalogue Number: 1011-2447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female