MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR8A-TRL-A0
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinical representative reported the electrode located at the tip of the lead had fallen off and was no longer attached.The provider then noticed that the receiver stylet was poking out the tip of the lead where the electrode had been.The receiver was able to completely pass through the lead and was sticking out the front instead of the back.The damaged device was not implanted.A new lead was provided and was successfully implanted.
Additional Manufacturer Narrative
The damaged product prior to use questionnaire was reviewed.The stimulator was delivered to curonix hq in a sealed sterilized kit.No visual defects were found on the stimulator or packaging.A potential cause of the failure could be a manufacturing issue.Curonix is unable to determine whether the stimulator was shipped from manufacturing defective or was damaged during transportation.Traceability efforts were unable to determine if the stimulator was shipped defectively.The lead could not be retrieved for investigation.The stimulator is used to treat pain.The cause of the damaged stimulator is likely due to a manufacturing issue (manufacture).This is the first complaint with this reported issue.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in damaged product prior to use.Damaged product prior to use rates remain acceptably low; thus, capa is not required.Damaged product prior to use rates will continue to be tracked and trended.Refer to issue (b)(4) for further investigation and risk assessment.

• 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: 18050220
• Report Number: 3010676138-2023-00224
• Device Sequence Number: 12628794
• Product Code: GZF
• UDI-Device Identifier: 00850051034376
• UDI-Public: (01)00850051034376(17)250601
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 11/01/2023

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: 06/01/2025
• Device Model Number: FR8A-TRL-A0
• Device Lot Number: SWO230605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2022
• 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
• Patient Sex: Unknown