MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number STQ4-RCV-A0, STQ4-RCV-B0

Device Problem Use of Device Problem (1670)

Patient Problem Pain (1994)

Event Date 02/01/2024

Event Type  Injury  

Event Description

The patient reported pain around where the neurostimulators were coiled.There were no signs of infection, the incisions healed nicely, and the neurostimulators did not migrate.Additionally, there were multiple conversations with the patient regarding therapy, but the patient was unwilling to turn the device on.An explant procedure was performed on (b)(6) 2024, and the patient is doing well.

Manufacturer Narrative

The other adverse events issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device at an off-label location, implanting the device too close to the targeted nerve, migration, and bone or tissue inadvertently punctured during the procedure have been ruled out as potential causes.However, the patient was extremely thin classifying the patient as a poor candidate.The stimulator is used to treat pain.The cause of the reported issue is due to the patient being a poor candidate due to health, weight, age, or mental capacity as the patient was extremely thin (user error-clinician).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, a capa is not required.Other adverse events issues rates will continue to be tracked and trended.Refer to (b)(4) for additional investigation details and risk assessment for late mdr reporting.

• 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: 18975337
• MDR Text Key: 338551505
• Report Number: 3010676138-2024-00039
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00850051034406
• UDI-Public: (01)00850051034406(17)250801(01)00850051034413(17)250801(21)2B17730-62
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/15/2023
• Device Model Number: STQ4-RCV-A0, STQ4-RCV-B0
• Device Lot Number: SWO230807, SWO230807
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/25/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female