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

Catalog Number	1011-1422
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Skin Infection (4544)
Date of Event	03/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
79 year old female implanted on (b)(6) 2024.On (b)(6) 2024, implant healing check occurred and no issues were noted.On (b)(6) 2024, patient was seen for activation and no issues were noted.Approximately 6 months post implantation on (b)(6) 2025, patient reported concern about implant site.On (b)96) 2025, patient was seen by physician and diagnosed with skin cellulitis - blanching erythema surrounding implant area.Patient was prescribed antibiotics (cephalexin, 500 mg, tid).On (b)(6) 2025, patient reported that antibiotics did not provide relief.Subject reported the implant site had gotten "hotter" in addition to stomach pain (began on (b)(6) 2025) and a canker sore (began (b)(6) 2025).On (b)(6) 2025, this was marked resolved and patient was explanted as antibiotics failed to resolve issue.On (b)(6) 2025, no abnormalities were noted at the healing explant check.As of (b)(6) 2025, cultures were negative for infection.The site maintains the initial diagnosis of skin cellulitis.
Additional Manufacturer Narrative
The device history file for both the ecoin device (b)(6) including the sterile load history report (241430) and the procedural kit lot (300-859) available at the implantation facility were reviewed and there were no related issues found.Physician was proctored at the beginning of (b)(6) 2024) for two cases.Proctoring documentation was reviewed and no related issues were noted.The device associated with the complaint was returned for investigation.The device passed all electrical tests.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 indeterminate origin.
Event or Problem Description
79 year old female implanted on (b)(6) 2024.On (b)(6) 2024, implant healing check occurred and no issues were noted.On (b)(6) 2024, patient was seen for activation and no issues were noted.Approximately 6 months post implantation on (b)(6) 2025, patient reported concern about implant site.On (b)(6) 2025, patient was seen by physician and diagnosed with skin cellulitis - blanching erythema surrounding implant area.Patient was prescribed antibiotics (cephalexin, 500 mg, tid).On (b)(6) 2025, patient reported that antibiotics did not provide relief.Subject reported the implant site had gotten "hotter" in addition to stomach pain (began on (b)(6) 2025) and a canker sore (began (b)(6) 2025).On (b)(6) 2025, this was marked resolved and patient was explanted as antibiotics failed to resolve issue.On (b)(6) 2025, no abnormalities were noted at the healing explant check.As of (b)(6) 2025, cultures were negative for infection.The site maintains the initial diagnosis of skin cellulitis.

• Brand Name: ECOIN PERIPHERAL NEUROSTIMULATOR
• Common Device Name: ECOIN UUI
• Manufacturer (Section D): VALENCIA TECHNOLOGIES; 28464 westinghouse place; valencia CA 91355
• Manufacturer (Section G): VALENCIA TECHNOLOGIES; 28464 westinghouse place; valencia 91355
• Manufacturer Contact: alejandra lopez ; 28464 westinghouse place; valencia, CA 91355 ; 8333264687
• MDR Report Key: 21830506
• Report Number: 3010878085-2025-00002
• Device Sequence Number: 18485251
• Product Code: QPT
• UDI-Device Identifier: 00860007896903
• UDI-Public: (01)00860007896903(11)240206(17)260206
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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
• Device Expiration Date: 02/06/2026
• Device Catalogue Number: 1011-1422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2024
• 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: 79 YR
• Patient Sex: Female