MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number STQ4-RCV-A0

Device Problem Use of Device Problem (1670)

Patient Problems Pain (1994); Skin Infection (4544)

Event Date 01/09/2024

Event Type  Injury  

Event Description

The patient reported pain, a rash, and skin infection near the implant site.The device remains implanted, and the patient is waiting for results from a metal allergy test.

Manufacturer Narrative

The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device after the expiration date, not prepping the skin with antiseptic solution, not irrigating the site with antibiotic solution before closure, using incorrect tools, and the patient not attending their post-op visit were ruled out as potential causes.However, the patient has a history of rashes/skin infections after coming in contact with metal and is being tested for a metal allergy.Results of the testing are not available at this time.The stimulator is used to treat pain.The cause of the reported issue is due to the patient being a poor candidate due to health, weight, age, or mental capacity as the patient has a history rashes/skin infections after coming in contact with metal (user error - clinician).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in surgical issues.Surgical issue rates remain acceptably low; thus, capa is not required. surgical issue rates will continue to be tracked and trended.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Type of Device: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): CURONIX LLC; 1310 park central blvd s; pompano beach FL 33064
• Manufacturer (Section G): CURONIX LLC; 1310 park central blvd s; pompano beach FL 33064
• Manufacturer Contact: tena jimmerson ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 18798658
• MDR Text Key: 336509608
• Report Number: 3010676138-2024-00025
• Device Sequence Number: 1
• Product Code: GZF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: STQ4-RCV-A0
• Device Lot Number: SWO230807
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/24/2023
• 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: 45 YR
• Patient Sex: Female