MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-RCV-A0, STQ4-SPR-B0
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported cramping after a spinal fusion on (b)(6) 2024 and requested reprogramming.On (b)(6) 2024 reprogramming attempts were made without success and an x-ray procedure was performed which showed a severed neurostimulator on the left side.The neurostimulator on the right was not seen on the x-ray.The physician believes the right neurostimulator was explanted and the left neurostimulator was severed during the spinal fusion.It is unknown which device was severed during the procedure, therefore, both devices are reported.The patient was still using the device after the spinal fusion with no relief.The patient would like to be implanted with a new neurostimulator and they will discuss options for the removal of the severed neurostimulator.
Additional Manufacturer Narrative
The loss of therapy/no therapy questionnaire was reviewed for potential causes of the reported issue.Potential causes of a severed neurostimulator are severe force applied to implant (patient fall/accident), severe force or bending during implantation, improper surgical technique, manufacturing issue, excessive pressure on the electrode array, and using incorrect tools at the time of the implant.The stimulator is used to treat pain.The cause of the reported issue is unrelated to curonix device as the physician believes the neurostimulator was severed during the spinal fusion (no fault found).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in loss of therapy/no therapy issues.Loss of therapy/no therapy issue rates remain acceptably low; thus, a capa is not required at this time.Loss of therapy/no therapy issue rates will continue to be tracked and trended.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Common Device Name: 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: 19629125
• Report Number: 3010676138-2024-00120
• Device Sequence Number: 20624531
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: (01)00818225020464(17)240201(01)00818225020495(17)231201(21)2B14441-90
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/01/2024
• Device Model Number: STQ4-RCV-A0, STQ4-SPR-B0
• Device Lot Number: SWO220228, SWO211209A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male