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 Code	Impaired Healing (2378)
Date of Event	03/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history file for both the ecoin device (501774) including the sterile load history report (249-602) and the procedural kit lot (300-688) available at the implantation facility were reviewed and there were no related issues found.The device associated with the complaint was returned for investigation.The device passed all electrical tests.Based on the information provided, the patient has rheumatoid arthritis as well as peripheral vascular disease in their lower legs.Per ecoin physician manual (903-1225 rev.V5), under contraindications "poor surgical candidates: the ecoin should not be implanted in patients who are poor surgical candidates.Poor surgical candidates include those who have: venous disease/insufficiency in the lower leg." the ecoin device is used to treat urgency urinary incontinence.The cause of the impaired healing is due to patient selection as the patient is a poor surgical candidate.
Event or Problem Description
The patient reported impaired wound healing at the incision site as well as exposure of the ecoin device.The wound was treated, several rounds of antibiotics were prescribed, and the patient was referred to wound care.An explant procedure was performed on (b)(6) 2025, the wound was irrigated, and sutures were placed.The patient attended a post-operative appointment after the explant procedure where the sutures were removed and it was noted the wound was healing well.

• 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: 22591432
• Report Number: 3010878085-2025-00003
• Device Sequence Number: 9190471
• Product Code: QPT
• UDI-Device Identifier: 00860007896903
• UDI-Public: (01)00860007896903(11)220527(17)240527
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 07/24/2025

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: 05/27/2024
• Device Catalogue Number: 1011-2447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2022
• 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: 73 YR
• Patient Sex: Female