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	Electric Shock (2554)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The issues after an mri questionnaire was reviewed for potential causes of the reported issue.Based on this review, the script was completed by curonix support with limited information.Potential causes of mri induced stimulation are product does not meet mri requirements and interference with a non-curonix device.The mri was performed on (b)(6) 2023, while the patient was completing the pns trial, which is noncompliant to the ifu.Per freedom peripheral nerve stimulator implantation of trial lead instructions for use (05-20100 rev.4), magnetic resonance imaging (mri) - the trial leads fr4a/fr8a are mr unsafe.Since the trial leads fr4a/fr8a are mr unsafe, the strong magnetic field of the mr system could attract or otherwise damage the device, and in the process cause serious harm to the patient or other people or damage to the mr system.The stimulator is used to treat pain.The cause of the reported issue is due to the product not meeting mri requirements as pns trial devices are not mri safe (user error - clinician).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in issues after an mri.Issues after an mri rates remain acceptably low; thus, capa is not required. issues after an mri rates will continue to be tracked and trended.
Event or Problem Description
The patient reported they felt a current/shock sensation during an mri.The mri was stopped immediately.The device is working fine since the incident.

• 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: 17021939
• Report Number: 3010676138-2023-00072
• Device Sequence Number: 6872790
• Product Code: GZF
• UDI-Device Identifier: 00818225020716
• UDI-Public: (01)00818225020716(17)230701(01)00818225020709(17)230701(21)2B13280-57
• 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: 2022
• 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): 05/30/2023

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: 07/01/2023
• Device Model Number: FR4A-TRL-A0, FR4A-TRL-B0
• Device Lot Number: SWO210712, SWO210714
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2021
• 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: 58 YR
• Patient Sex: Male