MAUDE Adverse Event Report: CURONIX LLC FREEDOM SPINAL CORD STIMULATOR

Model Number	FR8A-SPR-B0, FR8A-RCV-A0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	11/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported a very strong tingling feeling in their feet during an mri procedure.The patient is experiencing relief and the device is working.
Additional Manufacturer Narrative
The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, the questionnaire was completed with limited information.A potential cause of the reported issue is mri induced stimulation due to not meeting mri requirements.However, the mri was performed per the instructions for use.The waa was off and was not in the room during the mri.However, the patient has screws and pins in their lumbar which could contribute to the cause of the tingling sensation.The stimulator is used to treat pain.The cause of the reported issue is unknown.Therefore, conclusion has been selected as no problem/fault found.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in unintended stimulation/new pain issues.Unintended stimulation/new pain issue rates remain acceptably low; thus, capa is not required. unintended stimulation/new pain issue rates will continue to be tracked and trended.
Event or Problem Description
The patient reported a very strong tingling feeling in their feet during an mri procedure.The patient is experiencing relief and the device is working.
Additional Manufacturer Narrative
The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, the questionnaire was completed with limited information.A potential cause of the reported issue is mri induced stimulation due to not meeting mri requirements.However, the mri was performed per the instructions for use.The waa was off and was not in the room during the mri.However, the patient has screws and pins in their lumbar which could contribute to the cause of the tingling sensation.The stimulator is used to treat pain.The cause of the reported issue 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 unintended stimulation/new pain issues.Unintended stimulation/new pain issue rates remain acceptably low; thus, capa is not required. unintended stimulation/new pain issue rates will continue to be tracked and trended.Updated per fda (b)(4) correction 2.

• 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: 16017290
• Report Number: 3010676138-2022-00151
• Device Sequence Number: 6570480
• Product Code: GZB
• UDI-Device Identifier: 00818225020648
• UDI-Public: (01)00818225020648(17)211101(01)00818225020693(17)211101(21)211186-53
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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: 11/01/2021
• Device Model Number: FR8A-SPR-B0, FR8A-RCV-A0
• Device Lot Number: SWO191103, SWO191103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2019
• 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