MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR8A-TRL-A0, FR8A-TRL-B0
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	Blister (4537)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
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 in an off-label location, implanting the neurostimulator too close to the targeted nerve, and inadvertently puncturing bone or tissue during the procedure have been ruled out as potential causes.Additionally, severe force applied to the implant and not implanting the trial according to the ifu have been ruled out.However, the blisters are due to the tegaderm becoming lose which allowed moisture to get under the bandage.Additionally, the patient performed excessive twisting, bending, or stretching during their trial period which may have caused the neurostimulators to come out of the body.A curonix representative conducted a review of sterilization and packaging records for the respective product lot; curonix has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.The stimulator is used to treat pain.The cause of the blisters is due to the tegaderm becoming lose which allowed moisture to get under the bandage.However, the cause of the neurostimulators coming out of the body is due to excessive twisting or stretching as the patient reportedly felt a pull in their back while pulling their recliner up (user error-patient).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in other adverse events issues.Other adverse events issue rates remain acceptably low; thus, a capa is not required.Other adverse events issue rates will continue to be tracked and trended.
Event or Problem Description
The patient reported blisters under their bandage.Additionally, the patient reportedly felt a pull in their back while pulling their recliner up.Antibiotics were prescribed and the patient was provided instructions on how to care for the blisters.During their follow-up appointment, it was observed that the neurostimulators had come out of the body.The neurostimulators were pulled on (b)(6) 2024.

• 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: 20737917
• Report Number: 3010676138-2024-00245
• Device Sequence Number: 8648590
• Product Code: GZF
• UDI-Device Identifier: 00850051034376
• UDI-Public: (01)00850051034376(17)260301(01)00850051034390(17)260301(21)2B16734-16
• 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: 2024
• 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): 11/20/2024

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: 03/01/2026
• Device Model Number: FR8A-TRL-A0, FR8A-TRL-B0
• Device Lot Number: SWO240308, SWO240308
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2023
• 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: 68 YR
• Patient Sex: Female