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 Code	Post Operative Wound Infection (2446)
Date of Event	11/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
77-year-old female implanted on (b)(6) 2024.On (b)(6) 2024 patient reported "severe swelling".Patient was referred to urgent care by implanting physician and given antibiotics.On (b)(6) 2024 it was reported that "edema is present but looks significantly improved as evidenced by the wrinkles.The leg does not appear to be cellulitic, but does show some inflammation, which is to be expected.As of (b)(6) 2024, patient received antibiotics and recovered.
Additional Manufacturer Narrative
Supplemental mdr is submitted to clarify a few dates.Initial mdr was submitted to fda on 12/04/24, b4 has been updated.Additional clarification to field b5.It was previously reported "as of 12/5/24 patient received antibiotics and recovered" but the date should have been 12/3/24.

• 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 CA 91355
• Manufacturer Contact: alejandra lopez ; 28464 westinghouse pl; valencia, CA 91355 ; 8333264687
• MDR Report Key: 20848123
• Report Number: 3010878085-2024-00011
• Device Sequence Number: 3838844
• Product Code: QPT
• UDI-Device Identifier: 00860007896903
• UDI-Public: (01)00860007896903(11)240409(17)260409
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P200036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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: 04/09/2026
• Device Catalogue Number: 1011-1422
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• 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: 77 YR
• Patient Sex: Female