MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number STQ4-SPR-B0, STQ4-RCV-A0

Device Problem Use of Device Problem (1670)

Patient Problem Pain (1994)

Event Date 01/30/2024

Event Type  Injury  

Event Description

The patient reported loss of therapy and shooting pain in their leg.The patient undergoes regular nerve blocks every six months to help with pain management.The transmitters were reprogrammed, the patient is feeling much better, and the reprogramming is helping their pain.

Manufacturer Narrative

The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.The questionnaire was completed by quality with limited information.Potential causes of pain are programming parameters, contraindicating conditions, interference with a non-curonix device, migration, and change in posture or proximity of electrode to target nerve resulting in stimulation of the nerves outside of the target nerve.Attempts to reprogram the transmitters were successful and the issue was resolved.The stimulator is used to treat pain.The cause of the reported issue is due to programming parameters as the transmitters were reprogrammed and the patient's issue was resolved (user error - clinical representative).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in unintended stimulation/new pain.Unintended stimulation/new pain issue rates remain acceptably low; thus, capa is not required. unintended stimulation/new pain 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: 18764086
• MDR Text Key: 336053907
• Report Number: 3010676138-2024-00020
• 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: 02/22/2024

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: Lay User/Patient
• Device Expiration Date: 09/01/2022
• Device Model Number: STQ4-SPR-B0, STQ4-RCV-A0
• Device Lot Number: SWO200929, SWO201119
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2020
• 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 Sex: Female