MAUDE Adverse Event Report: VALENCIA TECHNOLOGIES ECOIN PERIPHERAL NUEROSTIMULATOR

Catalog Number 1011-1422

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 07/31/2023

Event Type  Injury  

Event 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.

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 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
• 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: 17603891
• MDR Text Key: 321747779
• Report Number: 3010878085-2023-00007
• Device Sequence Number: 1
• Product Code: QPT
• UDI-Device Identifier: 00860007896903
• UDI-Public: (01)00860007896903(11)220815(17)230815
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 07/31/2023
• Supplement Dates FDA Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• 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