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	Pain (1994)
Date of Event	04/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with the ecoin device on (b)(6) 2025 and the device was activated on (b)(6) 2025 with an amplitude setting of 2 ma.Additionally, the device was reprogrammed on (b)(6) 2026 with an amplitude setting of 4 ma.On (b)(6) 2026, the patient reported the ecoin device was causing periodic pain at the bottom of their incision near the ecoin device which prohibited them from some of their daily activities such as walking/exercising.The pain was not attributed to device stimulation.The patient detailed the pain began once the device was implanted and although the incision was healed, it was still very bothersome and was described as feeling "electrical or sharp." additionally, the patient reported their urinary symptoms were so severe, they had to take overactive bladder (oab) medication.An explant procedure was performed on (b)(6) 2026 due to patient experiencing pain.No further information is avaliable at this time and needs further resolution.
Additional Manufacturer Narrative
The adverse event is pending examination by the clinical principal investigator.The complaint will be updated when the examination is complete.The device history file for both the ecoin device (503275) including the sterile load history report (300-974) and the procedural kit lot (301355) 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 cause of the pain 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 unable to determine.

• 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: 25355437
• Report Number: 3010878085-2026-00009
• Device Sequence Number: 21305227
• Product Code: QPT
• UDI-Device Identifier: 00860007896903
• UDI-Public: (01)00860007896903(11)240716(17)260716
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P200036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 06/01/2026

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: 07/16/2026
• 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: 05/06/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• 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: 67 YR
• Patient Sex: Female