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 Codes	Pain (1994); Post Operative Wound Infection (2446)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with the ecoin device on (b)(6), 2026 and the device was activated on (b)(6) 2026 with an amplitude setting of 3 ma.On march 05, 2026, territory manager, (b)(6), received a phone call from the patient regarding an infection at the incision site and antibiotics were prescribed by the implanting physician.The patient described the infection as an allergy to the suturing.However, this was not confirmed by medical professionals.Cultures of the wound were obtained, and the results came back negative, indicating that no infection was present.Additionally, approximately one week before the phone call, the patient reportedly experienced shooting pain in the bottom of their foot and up their leg.The patient did not report any pain when the device was initially activated although they were very sensitive to the stimulation.On march 06, 2026, the territory manager met with the patient and turned the device off by placing it in shelf mode.Additionally, the patient saw a nurse and received advice on their wound.On march 11, 2026, the patient reported their ecoin device went off at 12:30pm despite the device being put in shelf mode on march 06, 2026.The patient met with the implanting physician on (b)(6) 2026 to discuss device removal.The device was explanted on (b)(6) 2026 and the patient has not experienced any additional pain.No further issues have been reported.
Additional Manufacturer Narrative
The device history file for both the ecoin device (b)(6) including the sterile load history report (301-151) and the procedural kit lot (301-705) available at the implantation facility were reviewed and there were no related issues found.Based on the information provided, the patient may have been picking at the wound which caused the original opening/discomfort.The explanted ecoin device associated with the complaint was not returned and could not be analyzed.Valencia technologies was unable to confirm the report of the device providing stimulation after being put in shelf mode.The ecoin device is used to treat urgency urinary incontinence.The cause of the reported issue 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 indeterminate origin.

• 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: aishwarya kalyankar ; 28464 westinghouse pl.; valencia, CA 91355
• MDR Report Key: 24772142
• Report Number: 3010878085-2026-00005
• Device Sequence Number: 18709255
• Product Code: QPT
• UDI-Device Identifier: 00860007896903
• UDI-Public: (01)00860007896903(11)240925(17)260925
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P200036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

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: 09/25/2026
• 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: 03/05/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2024
• 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: 75 YR
• Patient Sex: Female