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	Wound Dehiscence (1154); Cellulitis (1768); Skin Infection (4544)
Date of Event	02/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• 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: 24841184
• Report Number: 3010878085-2026-00006
• Device Sequence Number: 9056961
• Product Code: QPT
• UDI-Device Identifier: 00860007896903
• UDI-Public: (01)00860007896903(11)220503(17)240503
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P200036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/10/2026

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: 05/03/2024
• 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: 03/12/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female