MAUDE Adverse Event Report: CURONIX LLC FREEDOM SPINAL CORD STIMULATOR

Model Number	FR8A-RCV-A0, FR8A-SPR-B0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The loss of therapy/no therapy questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device in an off-label location, not achieving paresthesia on the table, not performing an x-ray immediately after the procedure to confirm placement, migration, inadequate fixation, and no attempts to reprogram the transmitter have been ruled out as potential causes.Additionally, severe force applied to the implant, and excessive twisting, bending, or stretching have been ruled out.However, the patient has psychological concerns.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 due to psychological concerns (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, a capa is not required at this time.Loss of therapy/no therapy issue rates will continue to be tracked and trended.
Event or Problem Description
The patient reported loss of therapy.After increasing the transmitter settings, the patient reported less pain in their feet.However, the patient is reportedly experiencing overstimulation in the morning and evenings when laying down on their back and stretching out their legs.The stretching leads to cramping in their calves and feet locking up.The transmitter settings were decreased and the patient will follow-up with their physician on (b)(6) 2024.The patient followed up with their physician and the transmitter settings were not changed.The patient is on a placebo program and due to psychological concerns, the transmitter settings were not changed.The patient was provided a replacement transmitter assembly and no other issues have been reported.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR
• Common Device Name: SPINAL CORD 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: 20835097
• Report Number: 3010676138-2024-00260
• Device Sequence Number: 11770372
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: (01)00818225020693(17)220901(01)00818225020648(17)211201(21)211257-71
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 12/02/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/01/2022
• Device Model Number: FR8A-RCV-A0, FR8A-SPR-B0
• Device Lot Number: SWO200922, SWO191202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2020
• 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 Age: 43 YR
• Patient Sex: Male