MAUDE Adverse Event Report: VALENCIA TECHNOLOGIES ECOIN PERIPHERAL NUEROSTIMULATOR

Catalog Number	1011-1422
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	07/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
68 year old female was implanted on (b)(6) 2023.They were seen at their 4 week activation appointment on (b)(6) 2023.There were no isses noted related to healing of the incision and they were cleared by the implanting physician for activation.On (b)(6) 2023, the patient called into the physician's offices to report observed signs of an infection (i.E.Redness and puss) and includes a picture of the site.The patient was prescribed antibioticis (augmentin).The implanting physician notified vtc sales personnel at this time.Updates for the patient were given to vtc on (b)(6) 2023 that the incision site and infection were "looking much better".Update on (b)(6) 2023, implanting physician communicated that the incision has "healed well" and "has no redness".

• Brand Name: ECOIN PERIPHERAL NUEROSTIMULATOR
• Common Device Name: 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: 17487994
• Report Number: 3010878085-2023-00005
• Device Sequence Number: 20644577
• Product Code: QPT
• UDI-Device Identifier: 00860007896903
• UDI-Public: (01)00860007896903(11)220607(17)230607
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P200036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 08/09/2023

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: 06/07/2023
• Device Catalogue Number: 1011-1422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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: 68 YR
• Patient Sex: Female