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

Catalog Number 1011-1422

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 04/24/2023

Event Type  Injury  

Manufacturer Narrative

The device history file for both the ecoin device including the sterile load history report and the procedural kit were reviewed and found no related issues.The patient was cleared for activation and activated on (b)(6) 2023.The device was not explanted and returned.

Event Description

80 year old female was implanted on (b)(6) 2023.They were seen at their 2 week wound healing check.There were no issues noted related to healing of the incision.On (b)(6) 2023, the patient was for their activation appointment and reported oozing and foul smell.An attending physician confirmed a slight superficial infection and prescribed an antibiotic.Activation appointment was delayed.On (b)(6) 2023, patient was seen again for an activation appointment after completing a 10 day antibiotic regimen.Patient's incision was cleared by an attending physician.

• Brand Name: ECOIN PERIPHERAL NUEROSTIMULATOR
• Type of Device: ECOIN UUI
• Manufacturer (Section D): VALENCIA TECHNOLOGIES; 28464 westinghouse place; valencia 91355
• Manufacturer (Section G): VALENCIA TECHNOLOGIES; 28464 westinghouse place; valencia 91355
• Manufacturer Contact: jacquelynn urso-bernick ; 28464 westinghouse place; valencia 91355 ; 8333264687
• MDR Report Key: 17003103
• MDR Text Key: 315944140
• Report Number: 3010878085-2023-00002
• Device Sequence Number: 1
• Product Code: QPT
• UDI-Device Identifier: 008660007896903
• UDI-Public: (01)008660007896903(11)220606(17)230606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2023
• Device Catalogue Number: 1011-1422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2023
• Initial Date FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female