MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number STQ4-RCV-A0

Device Problem Use of Device Problem (1670)

Patient Problem Hip Fracture (2349)

Event Date 03/08/2024

Event Type  Injury  

Manufacturer Narrative

The other adverse events questionnaire was reviewed for potential causes of the reported issue.Based on this review, the incident occurring before the implant of the device, implanting the device at an off-label location, and implanting the stimulator too close to the target nerve have been ruled out as potential causes.Additionally, bone or tissue was not inadvertently punctured during the procedure as the device was only implanted in the soft tissue.The commercial team member explained that the procedure went smoothly and nothing was out of the ordinary which would leave them to believe that the fractured pelvis occurred during the surgery.The commercial team member also noted that the patient has bone cancer and believes that the cancer could be in the patient's pelvis area.The stimulator is used to treat pain.Although the reported issue could not be confirmed, the patient is a poor candidate due to health, weight, age, mental capacity as the patient has bone cancer (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.

Event Description

The patient reported hip pain after their implant procedure.Additionally, the patient reported a pelvic fracture which they believe happened during the surgery.The patient did not provide imaging or information to confirm the fractured pelvis.They are feeling better and were advised to consult with their physician.

• 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: 19055358
• MDR Text Key: 339550242
• Report Number: 3010676138-2024-00047
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: (01)00818225020464(17)241001
• 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: 04/05/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: STQ4-RCV-A0
• Device Lot Number: SWO100522
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/27/2022
• 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: 73 YR
• Patient Sex: Male