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

Model Number	1011-2447
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Discomfort (2330)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Potential causes of cellulitis include: the patient having co-morbidities, the patient participating in any unusual/strenuous activity, or experiencing any trauma at the implant site.Although the patient does not have any contraindicating conditions, it was noted the patient has many allergies.The patient's programming file was reviewed and there were no related issues noted.The device history file for both the ecoin device (502750) including the sterile load history report (300-765) and the procedural kit lot (300-992, r00470) available at the implantation facility were reviewed and there were no related issues found.The device associated with the complaint was returned for investigation.However, failure analysis investigation has not been completed.
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 2 ma.The executive territory manager met with the patient on (b)(6) 2025 to turn off the device due to the patient feeling some discomfort.An ultrasound was performed which showed induration and possible cellulitis of the area.Additional information was received on november 04, 2025.The patient was experiencing pain around the site of the ecoin device.Antibiotics were prescribed and an explant procedure was performed on (b)(6) 2025.
Additional Manufacturer Narrative
Potential causes of cellulitis include: the patient having co-morbidities, the patient participating in any unusual/strenuous activity, or experiencing any trauma at the implant site.Although the patient does not have any contraindicating conditions, it was noted the patient has many allergies.The patient's programming file was reviewed and there were no related issues noted.The device history file for both the ecoin device ((b)(6)) including the sterile load history report (300-765) and the procedural kit lot (300-992, r00470) available at the implantation facility were reviewed and there were no related issues found.Failure analysis was not required as the patient did not experience discomfort associated with stimulation.Additionally, the patient had co-morbidities which may have been associated with the discomfort reported by the patient.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 unable to determine.
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 2 ma.The executive territory manager met with the patient on (b)(6) 2025 to turn off the device due to the patient feeling some discomfort.The patient did not experience any discomfort with stimulation.An ultrasound was performed which showed induration and possible cellulitis of the area.Additional information was received on november 04, 2025.The patient was experiencing pain around the site of the ecoin device.Antibiotics were prescribed.However, it did not resolve.An explant procedure was performed on (b)(6) 2025.

• 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: alicia pagliaro ; 28464 westinghouse pl.; valencia, CA 91355
• MDR Report Key: 23578011
• Report Number: 3010878085-2025-00006
• Device Sequence Number: 15847389
• Product Code: QPT
• UDI-Device Identifier: 00860007896903
• UDI-Public: (01)00860007896903(11)240320(17)260320
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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: 03/20/2026
• Device Model Number: 1011-2447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2024
• 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: 70 YR
• Patient Sex: Female