MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR8A-TRL-B0, FR8A-TRL-A0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported bleeding from the mouth following a trial procedure.The patient completed the trial, and the leads were pulled on (b)(6) 2023.The patient is currently doing well and is awaiting their permanent implant.
Additional Manufacturer Narrative
The other adverse events issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, using the waa during the incident, implanting the device at an off-label location, implanting the stimulator too close to the targeted nerve, and device migration requiring medical intervention to prevent serious injury or death have been ruled out as potential causes.The anesthesiologist confirmed the bleeding was due to anesthesia and intubation from a prior unrelated procedure.The stimulator is used to treat pain.The cause of the bleeding from the mouth is associated with the anesthesia intubation process from a prior unrelated procedure.The provided information does not evidence that the curonix device contributed to the reported issue and is unrelated to the curonix device (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, 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 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: 16896731
• Report Number: 3010676138-2023-00061
• Device Sequence Number: 17665335
• Product Code: GZF
• UDI-Device Identifier: 00818225020785
• UDI-Public: (01)00818225020785(17)241001(01)00818225020792(17)240701(21)2B15962-51
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 05/08/2023

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: 10/01/2024
• Device Model Number: FR8A-TRL-B0, FR8A-TRL-A0
• Device Lot Number: SWO221025, SWO220725
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2022
• 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 Age: 89 YR
• Patient Sex: Unknown