MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

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

Device Problem Use of Device Problem (1670)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994)

Event Date 10/31/2023

Event Type  Injury  

Manufacturer Narrative

The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, the unintended stimulation causing a heat sensation or shock and the patient feeling the unintended stimulation in a new area that is not targeted for therapy have been ruled out as potential causes.Additionally, migration was ruled out.However, the patient has a nevro device implanted which is not compliant with the ifu.Per freedom peripheral nerve stimulator system implantation of neurostimulator instructions for use, 05-20200, "active implantable or body-worn medical devices - safety has not been established for patients who use the freedom pns system with other active implantable or body-worn medical devices.These devices include other neurostimulation systems, insulin pumps, automated external defibrillators (aed), cochlear implants, and wearable medical sensors.Malfunction and/or damage could occur to either system, harming the patient or nearby people." the stimulator is used to treat pain.The cause of the reported issue is due to programming parameters as the issue was resolved after the device was reprogrammed.However, conclusion code has been selected as interference of a non-curonix device (user error - clinician) as the patient has a nevro device implanted.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.

Event Description

The patient reported overstimulation and pain after the transmitter assembly was switched from program 1 to program 2.The programming parameters were lowered, the patient was more comfortable, and there have been no other instances of overstimulation.The patient is doing well.

• 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: 18230314
• MDR Text Key: 329274380
• Report Number: 3010676138-2023-00250
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00850051034406
• UDI-Public: (01)00850051034406(17)250401(01)00818225020495(17)240701(21)2B15446-58
• 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: 11/29/2023

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, STQ4-SPR-B0
• Device Lot Number: SWO230410, SWO220726
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• 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