MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number STQ4-RCV-A0, STQ4-RCV-A0

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

Patient Problem Scar Tissue (2060)

Event Date 08/22/2022

Event Type  Injury  

Manufacturer Narrative

The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting an expired stimulator, not prepping the skin with antiseptic solution, not irrigating the site with antibiotic solution before closure, multiple tunneling attempts, using inappropriate tools and not prescribing antibiotics pre-operatively have been ruled out as potential causes of the reported issue.Additionally, the patient does not have any contradicting conditions.The implanting clinician explained the patient might have had a small tear in the capsule of scar tissue that was trying to form due to recent activity level, causing inflammation.A curonix representative conducted a review of sterilization and packaging records for the respective product lot; curonix has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.The stimulator is used to teat pain. the cause of the reported issue is due to excessive twisting or stretching as the patient recently increased their activity level (user error - patient).Refer to capa-2023-0001 for the investigation of late complaint reporting.

Event Description

The patient reported a lump on their back.X-rays and an ultrasound were performed, the lump was drained, the patient was prescribed antibiotics, and the incision has healed.The patient is doing well and is receiving therapy.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Type of Device: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): CURONIX LLC; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer (Section G): CURONIX LLC; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer Contact: alicia pagliaro ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 17005441
• MDR Text Key: 315962988
• Report Number: 3010676138-2023-00068
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: (01)00818225020464(17)240301(01)00818225020464(17)240301(21)2B14765-7
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2024
• Device Model Number: STQ4-RCV-A0, STQ4-RCV-A0
• Device Lot Number: SWO220322, SWO220322
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• 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: 51 YR
• Patient Sex: Female