MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number STQ4-RCV-A0

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

Patient Problems Pain (1994); Discomfort (2330)

Event Date 10/18/2023

Event Type  Injury  

Event Description

The patient reported tugging on the back of their leg, causing pain and discomfort.A procedure to explant and replace with a new lead was scheduled for on (b)(6) 2023.However, the procedure was postponed and a date has not yet been set.The patient has not been able to use their device.

Manufacturer Narrative

The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, the waa providing therapy when new pain occurred, the patient experiencing heat sensation/shock, changing the waa parameters intentionally or unintentionally, and the patient experiencing new pain in a new area that is not targeted for therapy have been ruled out as potential causes.Additionally, migration and the patient engaging in excessive twisting or stretching have been ruled out.The doctor believes the tunneling over the hamstring muscle has caused pulling and the device has scarred in the tunnel.As a result of the scarring across the muscle, the device will be explanted and replaced with a new lead with different positioning.The stimulator is used to treat pain.The cause of the reported issue is due to incorrect surgical technique (user error - clinician).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in unintended stimulation/new pain issues.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 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: 18121556
• MDR Text Key: 327997058
• Report Number: 3010676138-2023-00233
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: (01)00818225020464(17)240701
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/13/2023

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: Lay User/Patient
• Device Model Number: STQ4-RCV-A0
• Device Lot Number: SWO220726
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2022
• 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 Sex: Female