MAUDE Adverse Event Report: CURONIX LLC FREEDOM SPINAL CORD STIMULATOR

Model Number	FR8A-RCV-A0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3010676138-2023-00265
• Device Sequence Number: 7358896
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: (01)00818225020693(17)210701
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K182720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown