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	07/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
73 year old female implanted on (b)(6) 2023.At their 2 week healing check, the implanting physician noted a potential infection and patient was prescribed a round of antibiotics (i.E.Clindamycin).On (b)(6) 2023, the patient was seen for their activation appointment.The patient presented with continued signs of infection (i.E.Area was slightly red, and skin around incision was hard).On (b)(6) 2023, patient was cleared for activation by the physician.On 08/16/2023, an update was received that the patient is healed and the incision cleared by the physician.
Additional Manufacturer Narrative
On august 25, 2023, vtc received a report that the infection had regressed and the patient was explanted.Vtc received the explant on (b)(6) 2023.The failure analysis team performed visual inspection and ran final device electrical test on the device and found no related issues with the device.The investigation found no issues or use errors to the reported issue.The cause of the infection is not determined.
Event or Problem Description
73 year old female implanted on (b)(6) 2023.At their 2 week healing check, the implanting physician noted a potential infection and patient was precribed a round of antibiotics (i.E.Clyndamiacin).On (b)(6) 2023, the patient was seen for their activation appointment.The patient presented with continued signs of infection (i.E.Area was slightly red, and skin around incision was hard).On (b)(6) 2023, patient was cleared for activation by the physician.On (b)(6) 2023, an update was received that the patient is healed and the incision cleared by the physician.

• 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: 17603891
• Report Number: 3010878085-2023-00007
• Device Sequence Number: 12333172
• Product Code: QPT
• UDI-Device Identifier: 00860007896903
• UDI-Public: (01)00860007896903(11)220815(17)230815
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P200036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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: 08/15/2023
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• 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: 73 YR
• Patient Sex: Female