MAUDE Adverse Event Report: VALENCIA TECHNOLOGIES ECOIN PERIPHERAL NUEROSTIMULATOR; 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	11/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
81 year old female implanted on (b)(6) 2023 presented with a possible infection on (b)(6) 2023.Patient had a small superficial dehiscence.Patient's wound was debrided and prescribed an antibiotic.Prior to the report, the patient was seen on (b)(6) 2023 for activation.At that time, there were no signs of an infection and the activation was completed with no related issues noted.Update provided on (b)(6) 2023 communicated that the patient is "healing very well".Physician and patient are happy with the progress.Patient was switched from weekly follow-ups to a monthly check in.

• Brand Name: ECOIN PERIPHERAL NUEROSTIMULATOR
• 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: jacquelynn urso-bernick ; 28464 westinghouse place; valencia, CA 91355 ; 8333264687
• MDR Report Key: 18500235
• Report Number: 3010878085-2024-00001
• Device Sequence Number: 15429018
• Product Code: QPT
• UDI-Device Identifier: 00860007896903
• UDI-Public: (01)00860007896903(11)220411(17)240411
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P200036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 01/11/2024

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: 04/11/2024
• 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: Not provided
• Initial Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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: 81 YR
• Patient Sex: Female