MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR4A-TRL-A0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	04/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, interference from a non-curonix device was ruled out as a potential cause.However, overstimulation was occurring due to the close proximity of device to nerve after the aggressive pat down.The stimulator is used to treat pain.The cause of the reported issue is due to severe force applied to the implant as the tsa agent aggressively patted down the area (user error).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in unintended stimulation/new pain.Unintended stimulation/new pain rates remain acceptably low; thus, a capa is not required.Unintended stimulation/new pain rates will continue to be tracked and trended.
Event or Problem Description
The patient reported mild, random zapping sensations (not painful) that occurred on occasion several days into the trial.They traveled the day prior and reports tsa performed an aggressive "pat down" of area prior to this occurring.The patient was instructed to power off the device and meet with a local clinical representative.The transmitter settings were changed (decreased) and the sensation has not occurred again.

• 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: 19218088
• Report Number: 3010676138-2024-00068
• Device Sequence Number: 7026001
• Product Code: GZF
• UDI-Device Identifier: 00850051034369
• UDI-Public: (01)00850051034369(17)250801
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/30/2024

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: 08/01/2025
• Device Model Number: FR4A-TRL-A0
• Device Lot Number: SWO230807
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2023
• 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
• Patient Age: 61 YR
• Patient Sex: Male