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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2024, the commercial team member attempted to follow-up with the patient regarding their trial and was informed that the patient had passed away on (b)(6) 2024.The commercial team member last spoke with the patient on (b)(6) 2024 and they were doing well with the trial and getting great relief in their back.Upon notifying the physicians office of the patient's death, the physician reported the patient had a fungal infection that had caused the patient to lose a lot of weight.The patient wanted to pursue the pns trial as a means of treating their back pain.
Additional Manufacturer Narrative
The devices associated with this complaint were not returned and could not be analyzed by engineering.Attempts to recover the device were unsuccessful, preventing engineering from performing investigation.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 device too close to the targeted nerve, and inadvertently puncturing the bone or tissue during the procedure have been ruled out as potential causes.The patient had a fungal infection that had caused the patient to lose a lot of weight.It is not believed that the device had anything to do with the death of the patient.The stimulator is used to treat pain.The cause of the reported unrelated to the curonix device as the patient had a pre-existing fungal infection (no fault found).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.

• 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: 20252715
• Report Number: 3010676138-2024-00183
• Device Sequence Number: 15612840
• Product Code: GZF
• UDI-Device Identifier: 00850051034369
• UDI-Public: (01)00850051034369(17)260501(01)00850051034383(17)260401(21)2B19498-5
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/18/2024

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: 05/01/2026
• Device Model Number: FR4A-TRL-A0, FR4A-TRL-B0
• Device Lot Number: SWO240521, SWO240430
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TRANSMITTER ASSEMBLY LN:01113-LT SN:(B)(6); TRANSMITTER ASSEMBLY LN:01113-LT SN:(B)(6)
• Outcome Attributed to Adverse Event: Death
• Patient Age: 60 YR
• Patient Sex: Female