MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

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

Patient Problems Perforation of Vessels (2135); Swelling/ Edema (4577)

Event Date 02/09/2024

Event Type  Injury  

Event Description

The procedure was aborted due to the patient having an issue with the iv as the patient's veins kept blowing and caused swelling in the patient's arm.The trial procedure was rescheduled to (b)(6) 2024, where the patient's iv was successfully inserted in the operating room (or).The patient is doing well, had a successful trial, and will be moving forward with a permanent implant procedure.

Manufacturer Narrative

The other adverse events issue questionnaire was reviewed for potential causes by quality with limited information.Patient contraindicating conditions have been ruled out as a potential cause.However, the patient has small veins and it is sometimes hard to get an iv started on them, which could have potentially contributed to the issue.The stimulator is used to treat pain.The cause of the reported is due to the patient having small veins.The provided information does not evidence that the curonix device contributed to the reported issue and the cause of the reported issue was due to the patient having small veins (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 issue rates remain acceptably low; thus, a capa is not required at this time.Other adverse events issue 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 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: 19048995
• MDR Text Key: 339433323
• Report Number: 3010676138-2024-00046
• Device Sequence Number: 1
• Product Code: GZF
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 57 YR
• Patient Sex: Female