MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR8A-TRL-B0
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The no therapy/loss of therapy questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device at an off-label location, no attempts to reprogram the transmitter assembly, and inadequate fixation have been ruled out as potential causes.Additionally, the patient did not engage in activities with excessive twisting/bending or experience a fall.However, migration was confirmed.The stimulator is used to treat pain.The cause of the reported issue is migration.However, the cause of the migration is unknown.Therefore, conclusion has been selected as no problem/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.Refer to (b)(4) for the investigation of late complaint reporting.
Event or Problem Description
The patient reported feeling no therapy and stimulation and discomfort in the groin area during superior clonal placement.Additionally, migration was confirmed via x-ray.An explant procedure was performed (b)(6) 2023.Removing the lead and turning off the transmitter resolved the stimulation.However, after the explant, the patient decided not to move forward with a re-trial.The physician is working with the patient on an alternative treatment option.
Event or Problem Description
The patient reported feeling no therapy and stimulation and discomfort in the groin area during superior clonal placement.Additionally, migration was confirmed via x-ray.An explant procedure was performed (b)(6) 2023.Removing the lead and turning off the transmitter resolved the stimulation.However, after the explant, the patient decided not to move forward with a re-trial.The physician is working with the patient on an alternative treatment option.
Additional Manufacturer Narrative
The no therapy/loss of therapy questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device at an off-label location, no attempts to reprogram the transmitter assembly, and inadequate fixation have been ruled out as potential causes.Additionally, the patient did not engage in activities with excessive twisting/bending or experience a fall.However, migration was confirmed.The stimulator is used to treat pain.The cause of the reported issue is migration.However, the cause of the migration is unknown.The investigation findings do not lead to a clear conclusion about the cause of migration.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 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.Refer to issue-2023-0008 for the investigation of late complaint reporting.Updated per fda capa-2023-0013 correction 2.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Common Device Name: 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: 17293305
• Report Number: 3010676138-2023-00099
• Device Sequence Number: 4195382
• Product Code: GZF
• UDI-Device Identifier: 00818225020785
• UDI-Public: (01)00818225020785(17)250101
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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: 01/01/2025
• Device Model Number: FR8A-TRL-B0
• Device Lot Number: SWO230116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male