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

Catalog Number	1011-2447
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146)
Date of Event	05/11/2026
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 4 ma.The device was reprogrammed on (b)(6) 2025 with an amplitude setting of 5 ma.On (b)(6) 2026, the patient went in for an mri scan due to experiencing some severe lower back pain.The patient was cleared for the mri and the guidelines for having an mri with the ecoin device were reviewed.However, the mri technicians taped the patient magnet around the patient's leg over the ecoin device in order to "avoid stimulation during the scan." the patient was put into the mri and the scan began.As the scan began, the patient magnet "shot off" of the patient's leg and the patient experienced a burning sensation through their ankle and foot.The mri was immediately aborted.As of on (b)(6) 2026, the device remains implanted, the patient has not reported any additional problems and stated their ecoin device is running every four days as it previously was.The patient will be evaluated again by the implanting physician in six weeks from their last visit.No further issues have been reported at this time.
Additional Manufacturer Narrative
A review of the device history file resulted in no related issues.Based on the information provided, the mri technician was non-compliant to the instructions for use and taped patient magnet around the patient's leg prior to beginning the mri scan.Per ecoin peripheral neurostimulator system patient manual, 903-1236 rev.V3, "the patient controller magnet is mr unsafe and should never enter an mri room or facility.The other parts of the ecoin peripheral neurostimulator system (used by your physician or a technically trained field person) are mr conditional." the ecoin device is used to treat urgency urinary incontinence.The cause of the burning sensation during the mri is due to non-compliance to the ifu-mri facility.

• 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: 25451492
• Report Number: 3010878085-2026-00010
• Device Sequence Number: 8754120
• Product Code: QPT
• UDI-Device Identifier: 00860007896903
• UDI-Public: (01)00860007896903(11)240529(17)260529
• 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
• 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): 06/09/2026

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: 05/29/2026
• 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: 05/11/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2024
• 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: 69 YR
• Patient Sex: Female