MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number FR8A-TRL-B0, FR8A-TRL-A0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/10/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 314845437
• Report Number: 3010676138-2023-00061
• Device Sequence Number: 1
• 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
• Reporter Country Code: US
• PMA/PMN Number: K171366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FR8A-TRL-B0, FR8A-TRL-A0
• Device Lot Number: SWO221025, SWO220725
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 89 YR