MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

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 at an off-label location has been ruled out as a potential cause.Potential causes of the reported issue are severe force applied to implant, 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.However, the neurostimulator was fractured while attempting to explant the device.The stimulator is used to treat pain.The cause of the fractured lead is due to incorrect surgical technique as the neurostimultor was fractured during the explant procedure (user error - clinician).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

As of (b)(6) 2020 the patient was receiving adequate therapy and the devices were helping with ilioinguinal and low back pain.On january 26, 2024, support received a call regarding mri clearance.An explant procedure was performed on (b)(6) 2020 where one neurostimulator was completely removed and the other was partially removed as it was fractured while attempting to explant.The reason for the explant procedure is unknown and there are no plans to remove the remaining portion.Additionally, it is unknown which device remains partially implanted.The surgeon noted the remaining portion of the neurostimulator is in the muscle tissue and since it isn't causing damage, harm, or risk, they didn't advise the patient to have it removed.

Manufacturer Narrative

The other adverse events issues questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device at an off-label location has been ruled out as a potential cause.Potential causes of the reported issue are severe force applied to implant, 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.However, the neurostimulator was fractured while attempting to explant the device.The stimulator is used to treat pain.The cause of the fractured lead is due to incorrect surgical technique as the neurostimultor was fractured during the explant procedure (user error - clinician).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

As of (b)(6) 2020 the patient was receiving adequate therapy and the devices were helping with ilioinguinal and low back pain.On (b)(6) 2024, support received a call regarding mri clearance.An explant procedure was performed on (b)(6) 2020 where one neurostimulator was completely removed and the other was partially removed as it was fractured while attempting to explant.The reason for the explant procedure is unknown and there are no plans to remove the remaining portion.Additionally, it is unknown which device remains partially implanted.The surgeon noted the remaining portion of the neurostimulator is in the muscle tissue and since it isn't causing damage, harm, or risk, they didn't advise the patient to have it removed.

• 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: 18764042
• MDR Text Key: 336052881
• Report Number: 3010676138-2024-00017
• 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,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2021
• Device Model Number: STQ4-RCV-A0, STQ4-SPR-B0
• Device Lot Number: SWO190410, SWO190424
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/29/2018
• 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 Age: 82 YR
• Patient Sex: Male