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); Numbness (2415); Electric Shock (2554)

Event Date 01/30/2024

Event Type  Injury  

Manufacturer Narrative

The other adverse events issues questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device in an off-label location was ruled out as potential root cause.The clinical representative confirmed the patient does not have any contraindicating conditions, the neurostimulator was not implanted too close to the targeted nerve, and the needle did not inadvertently puncture bone or tissue during the procedure.It is unknown if the lead migrated.After reprogramming the transmitter, the patient improved and is no longer experiencing the burning and shocking.The stimulator is used to treat pain.The cause of the burning and shocking at the receiver pocket site is due to programming parameters as reprogramming the transmitter assembly resolved the reported issue (user error-clinical representative).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in other adverse events issues.Other adverse events issues rates remain acceptably low; thus, a capa is not required.Other adverse events issues rates will continue to be tracked and trended.

Event Description

The patient reported burning and shocking pain at the receiver pocket site and numbness in the side of their leg.The transmitter was reprogrammed, the patient has improved, and is no longer experiencing the shocking and burning.

• 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: 18813518
• MDR Text Key: 336621071
• Report Number: 3010676138-2024-00026
• 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: 02/29/2024

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 Model Number: STQ4-RCV-A0
• Device Lot Number: SWO230807
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2023
• 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
• Treatment: TRANSMITTER ASSEMBLY SN:(B)(6), LN: 00963-DT; TRANSMITTER ASSEMBLY SN:(B)(6), LN: 00963-DT
• Patient Sex: Female