MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number STQ4-RCV-A0

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

Patient Problem Pain (1994)

Event Date 11/15/2023

Event Type  Injury  

Event Description

The patient reported increased pain after experiencing a fall.The emergency room physician noted muscle or soft tissue injury from the fall and the device was reprogrammed.Additionally, the physician's office scheduled their recommendations for the patient based on their new symptoms that are unrelated to their current stimulator.The curonix representative has attempted to contact the patient.However, all attempts have been unsuccessful.No additional information is available at this time.

Manufacturer Narrative

The loss of therapy/no therapy issues questionnaire was reviewed for potential causes of the reported issue.Based on this review, not achieving therapy, implanting the device at an off-label location, not performing x-rays immediately after the procedure to confirm the device placement, and not implanting the device per ifu have been ruled out as potential causes.However, the patient suffered a fall, which is a contributing factor to the occurrence.The stimulator is used to treat pain.The cause of the reported issue is due to severe force applied to the implant as the patient experienced a fall (user error - patient).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in loss of therapy/no therapy issues.Loss of therapy/no therapy issue rates remain acceptably low; thus, capa is not required. loss of therapy/no therapy 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 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: 18312173
• MDR Text Key: 330294976
• Report Number: 3010676138-2023-00261
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: (01)00818225020464(17)240701
• 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: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• 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: SWO220726
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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: Female