MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR4A-TRL-A0, FR4A-TRL-B0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Pain (1994)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, migration, and requiring medical intervention to prevent serious injury or death have been ruled out as potential causes of the reported issue.The pain experienced by the patient was related to a prior injury to l5-s1, and she complained that the pain medication the doctor prescribed was not working.The medication had been changed, and the physician believes the patient might have experienced withdrawal side effects.The stimulator is used to treat pain.The cause of the reported pain is due a herniated disc (l5-s1).The cause of the itching is unknown.Therefore, conclusion has been selected as no problem/fault found, as the device could not be attributed to the cause of the reported incident.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, capa is not required.Other adverse events issues rates will continue to be tracked and trended.
Event or Problem Description
The patient reported an itching reaction during their trial and asked to have the leads removed early.They were given cortisone cream to treat the area.The patient was also complaining of severe right sided pain in their back and leg, which the doctor said was related to their l5-s1 herniated disc.An explant procedure was performed on (b)(6) 2023.The patient is no longer itching and there was no infection present.
Additional 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 and migration have been ruled out as potential causes of the reported issue.The pain experienced by the patient was related to a prior injury to l5-s1, and she complained that the pain medication the doctor prescribed was not working.The medication had been changed, and the physician believes the patient might have experienced withdrawal side effects.The stimulator is used to treat pain.The cause of the reported pain is due a herniated disc (l5-s1).The cause of the itching is due to the patient experiencing withdrawal side effects.Therefore, conclusion has been selected as no problem/fault found, as the device could not be attributed to the cause of the reported incident.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, capa is not required.Other adverse events issues rates will continue to be tracked and trended.Updated per fda capa-2023-0013 correction 2.
Event or Problem Description
The patient reported an itching reaction during their trial and asked to have the leads removed early.They were given cortisone cream to treat the area.The patient was also complaining of severe right sided pain in their back and leg, which the doctor said was related to their l5-s1 herniated disc.An explant procedure was performed on (b)(6) 2023.The patient is no longer itching and there was no infection present.

• 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: 16501598
• Report Number: 3010676138-2023-00024
• Device Sequence Number: 6129289
• Product Code: GZF
• UDI-Device Identifier: 00818225020716
• UDI-Public: (01)00818225020716(17)240701(01)00818225020709(17)240901(21)2B16244-26
• Combination Product (Y/N): N
• 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: 07/01/2024
• Device Model Number: FR4A-TRL-A0, FR4A-TRL-B0
• Device Lot Number: SWO220708, SWO220920
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2022
• 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 Sex: Unknown