MAUDE Adverse Event Report: VALENCIA TECHNOLOGIES ECOIN PERIPHERAL NUEROSTIMULATOR

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 11/09/2023

Event Type  Injury  

Event Description

73 year old female implanted on 10/17/23.At their activation appointment on (b)(6) 2023 presented with an infection at the incision site.Patient reported discharge and redness at the incision which began on (b)(6) 2023.Patient was started on 10 day oral antibiotic regimen on (b)(6) 2023.As of (b)(6) 23, patient is scheduled for activation on (b)(6) 23.

• Brand Name: ECOIN PERIPHERAL NUEROSTIMULATOR
• Type of Device: ECOIN
• 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: 18332568
• MDR Text Key: 330548256
• Report Number: 3010878085-2023-00008
• Device Sequence Number: 1
• Product Code: QPT
• UDI-Device Identifier: 00860007896903
• UDI-Public: (01)00860007896903(11)220407(17)240407
• Combination Product (y/n): Y
• 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: 11/14/2023

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: 04/07/2024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• 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: 73 YR
• Patient Sex: Female