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	Erythema (1840)
Date of Event	07/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history file for both the ecoin device (b)(6) including the sterile load history report (300-677) and the procedural kit lot (300-755) 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 redness was resolved and the incision site was healing as expected.
Event or Problem Description
The patient was implanted with the ecoin device on (b)(6) 2024.On (b)(6) 2024, the patient reported mild redness at the incision site and antibiotics were prescribed.The redness resolved by (b)(6) 2024 and there was no lasting impairment to wound healing or delays to activation which occurred on (b)(6) 2024.

• 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: 24918586
• Report Number: 3010878085-2026-00008
• Device Sequence Number: 21415214
• Product Code: QPT
• UDI-Device Identifier: 00860007896903
• UDI-Public: (01)00860007896903(11)220711(17)240711
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P200036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/17/2026

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: 07/11/2024
• 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: 03/18/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2022
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female