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

Model Number 1011-2447

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 06/07/2023

Event Type  Injury  

Event Description

Overweight, female patient was re-implanted on (b)(6) 2023 per patient's request as part of the pivotal clinical study.They were seen for a wound healing check on (b)(6) 2023.There were no related issues noted at the healing check.On (b)(6) 2023, patient was on vacation aboard a cruise ship and noticed redness at the incision site.The patient was seen at a walk in clinic and reported trauma at the site on (b)(6) 2023.The patient was prescribed an antibiotic.Patient messaged the implanting physician's clinic, whom agreed with the treatment.On (b)(6) 2023, patient communicated that the incision site was improving.On (b)(6) 2023, the patient was seen by the implanting physician who noted the infection had cleared.Patient was activated on (b)(6) 2023.

• 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: 17279119
• MDR Text Key: 318583427
• Report Number: 3010878085-2023-00004
• Device Sequence Number: 1
• Product Code: QPT
• 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: Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2023

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 Expiration Date: 05/26/2023
• Device Model Number: 1011-2447
• Device Catalogue Number: 1011-1422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: No
• 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: 66 YR
• Patient Sex: Female