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

Model Number 1011-2447

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

Patient Problems Purulent Discharge (1812); Post Operative Wound Infection (2446)

Event Date 10/04/2022

Event Type  Injury  

Event Description

75 year old female with a history of smoking was implanted on (b)(6) 2022.At their two-week wound healing check, they came in with an infection at the implant site.The implanting physician prescribed antibiotics.Approximately one week later ((b)(6) 2022), the patient came in for their activation appointment and noted the patient's infection had significantly improved and they were cleared for activation.On (b)(6) 2022, the patient contacted their primary care physician and additional antibiotics were prescribed.The patient was directed to their implanting physician and was determined to have an actively draining wound on (b)(6) 2022.During the explant procedure on (b)(6) 2022, an infection was confirmed in the area above the incision site.

Event Description

75 year old female implanted on (b)(6) 2022.At their two-week wound healing check, they came in with an infection at the implant site.The implanting physician prescribed antibiotics.Approximately one week later ((b)(6) 2022), the patient came in for their activation appointment and noted the patient's infection had significantly improved and they were cleared for activation.An additional antibiotic was added at this time, the patient continued antibiotics until the end of october.Patient was seen weekly until (b)(6) 2022 where it was determined their infection had resolved itself.On (b)(6) 2022, the patient contacted their primary care physician and additional antibiotics were prescribed.The patient was directed to their implanting physician and was determined to have an actively draining wound on (b)(6) 2022.During the explant procedure on (b)(6) 2022, an infection was confirmed in the area above the incision site.

Manufacturer Narrative

The surgical notes associated with the patient's procedure was reviewed.There were no concerns noted by the proctor.Additionally, the device history file for both the ecoin device including the sterile load history report and the lots of procedural kits available at the implantation facility were reviewed and there were no related issues found.The device was received by vtc on 12/9/22.The failure analysis team performed a visual inspection (12/12/22) and ran final device electrical test (12/15/22) 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 NEUROSTIMULATOR
• Type of Device: ECOIN UUI
• Manufacturer (Section D): VALENCIA TECHNOLOGIES; 28464 westinghouse pl.; valencia CA 91355
• Manufacturer (Section G): VALENCIA TECHNOLOGIES; 28464 westinghouse pl.; valencia CA 91355
• Manufacturer Contact: alicia pagliaro ; 28464 westinghouse pl.; valencia, CA 91355
• MDR Report Key: 15972873
• MDR Text Key: 305420065
• Report Number: 3010878085-2022-00001
• Device Sequence Number: 1
• Product Code: QPT
• UDI-Device Identifier: 00860007896903
• UDI-Public: (01)00860007896903(11)220110(17)221010
• 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,Followup
• Report Date: 01/06/2023

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: 10/10/2022
• Device Model Number: 1011-2447
• Device Catalogue Number: 1011-1422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 10/14/2022
• Supplement Dates FDA Received: 01/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2022
• 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: 75 YR
• Patient Sex: Female