MAUDE Adverse Event Report: CURONIX LLC FREEDOM SPINAL CORD STIMULATOR

Model Number FR8A-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  

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, and not performing x-rays immediately after the procedure to confirm the device placement have been ruled out as potential causes.Additionally, the patient did not experience a fall and the device was fixated correctly at the time of the implant.The clinical representative verified the device migrated and the patient has metal implants in their back.The cause of the migration is unknown.The stimulator is used to treat pain.The cause of the reported issue is due to the migration.However, the cause of the migration is unknown.The investigation findings do not lead to a clear conclusion about the cause of the reported issue.Therefore, conclusion has been selected as unable to determine root cause.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. .

Event Description

The patient reported upper back pain and decreased therapy.X-rays confirmed device migration.The device was reprogrammed although the pain was unchanged with or without the stimulator in use.The patient reported the stimulator is helping, but just not enough.A ct scan is scheduled however an exact date was not provided.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR
• Type of Device: SPINAL CORD 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: 18328228
• MDR Text Key: 330510290
• Report Number: 3010676138-2023-00265
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: (01)00818225020693(17)210701
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182720
• 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: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2021
• Device Model Number: FR8A-RCV-A0
• Device Lot Number: SWO190719
• 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: 06/27/2019
• 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