MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number STQ4-RCV-A0

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 01/03/2024

Event Type  Injury  

Manufacturer Narrative

The loss of therapy/no therapy questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device at an off-label location, not performing an x-ray immediately after to confirm placement, inadequate fixation, and no attempts to reprogram the transmitter have been ruled out as potential causes.Migration was confirmed; however, the cause of migration is unknown.The stimulator is used to treat pain.The cause of the pain is due to migration.However, the cause of the migration is unknown.The investigation findings do not lead to a clear conclusion about the cause of the reported issue.Therefore, conclusion has been selected as unable to determine root cause.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in surgical issues.Surgical issue rates remain acceptably low; thus, capa is not required. surgical issue rates will continue to be tracked and trended.

Event Description

The patient reported large pulsating pains in the knee that are relieved with removing the device.Migration was confirmed via x-ray and attempts were made to reprogram the transmitter.An explant or revision procedure is not scheduled at this time as the physician wants to explore an scs trial.The patient is stable, but having pain in the knee that was previously not present during trial or initially after permeant procedure.

Manufacturer Narrative

The loss of therapy/no therapy questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device at an off-label location, not performing an x-ray immediately after to confirm placement, inadequate fixation, and no attempts to reprogram the transmitter have been ruled out as potential causes.However, migration was confirmed and the implanting physician believes the device was placed at too steep of an angle, thus affecting efficacy.After the replacement procedure, fluoroscopy and an x-ray were used to confirm device placement.The stimulator is used to treat pain.The cause of the reported issue is due improper surgical technique as the implanting clinical implanted the device at too steep of an angle (user error - clinician).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in loss of therapy/no therapy.Loss of therapy/no therapy rates remain acceptably low; thus, capa is not required. loss of therapy/no therapy rates will continue to be tracked and trended.

Event Description

The patient reported large pulsating pains in the knee that are relieved with removing the device.Migration was confirmed via x-ray and attempts were made to reprogram the transmitter.An explant or revision procedure is not scheduled at this time as the physician wants to explore an scs trial.The patient is stable, but having pain in the knee that was previously not present during trial or initially after permeant procedure.Additional information was obtained on (b)(6) 2024.An explant procedure was performed on (b)(6) 2024, and a new neurostimulator was implanted.The patient is feeling well and is healing appropriately.

• 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: 18582565
• MDR Text Key: 333773470
• Report Number: 3010676138-2024-00007
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00850051034406
• UDI-Public: (01)00850051034406(17)250401
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• 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: SWO230410
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention