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

Model Number	1011-2447
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	04/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
80 year old female was implanted on (b)(6) 2023.They were seen at their 2 week wound healing check as well their 4 week activation appointment.There were no issues noted related to healing of the incision.On (b)(6) 2023, they were seen by the implanting physician and presented with clear signs of infection at the incision site (i.E.Redness and soreness).Additionally, the implant was visible.The physician explanted the device.The patient's wound was debrided, irrigated and packed and they were prescribed antibiotics.Patient was referred to a wound clinic.An update was received on 04/24/2023 confirming the patient is under the care of a wound clinic.No further issue reported related to healing of the site.
Additional Manufacturer Narrative
The surgical notes associated with patient's procedure were reviewed.There were no concerns noted by the company proctor assigned to the patient's procedure.Additionally, the device history file for both the ecoin device including the sterile load history report and the lots of the procedural kit available at the implantation facility were reviewed and there were no related issues found.The device was received by vtc on 04/18/2023.The failure analysis team performed visual inspection and ran final device electrical test on the device and found no related issues with the device.The investigation found no issues or use errors related to the reported issue.The cause of the infection is not determined.

• 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
• MDR Report Key: 16828341
• Report Number: 3010878085-2023-00001
• Device Sequence Number: 7131799
• Product Code: QPT
• UDI-Device Identifier: 00860007896903
• UDI-Public: (01)00860007896903(11)220303(17)230303
• 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: 2023
• Device Explanted 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): 04/27/2023

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: 03/23/2023
• Device Model Number: 1011-2447
• Device Catalogue Number: 1011-1422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2022
• 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: 80 YR
• Patient Sex: Female