MAUDE Adverse Event Report: CURONIX LLC FREEDOM SPINAL CORD STIMULATOR

Model Number	FR8A-RCV-A0, FR8A-SPR-B0
Medical Device Problem Codes	Circuit Failure (1089); Fracture (1260); Use of Device Problem (1670); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/16/2024
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 performing an x-ray immediately after the procedure to confirm placement, and no attempts to reprogram the transmitter have been ruled out as potential causes.However, the patient experienced a fall during a snowboarding accident, migration was confirmed via x-ray, and the implanting clinician did not coil the receiver during the implant procedure.The medical team believes that during the snowboarding accident, the device was pinched/cut between the lamina of the two vertebrae at the level of epidural entry.The stimulator is used to treat pain.The cause of loss of therapy, migration, and the fractured device is due to severe force applied to the implant (patient fall, accident) as the patient fell during a snowboarding accident (user error- patient).Additionally, inadequate fixation was identified as the implanting clinician did not coil the receiver during the implant procedure (user error- clinician).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 and increased pain after a snowboarding accident and migration was confirmed via x-ray.Attempts were made to change the transmitter settings with no success and an explant procedure was scheduled for (b)(6) 2024.During the explant procedure, one of the neurostimulators was removed without issue.However, the second device was broken off at the lamina and could not be completely explanted.The patient was referred to a neurosurgeon to perform a micro-laminotomy to remove the fragment of the device that remained implanted.On (b)(6) 2024, the remaining portion of the device was explanted.The patient is doing well and will be implanted with two new neurostimulators (date is unknown).
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 performing an x-ray immediately after the procedure to confirm placement, and no attempts to reprogram the transmitter have been ruled out as potential causes.However, the patient experienced a fall during a snowboarding accident, migration was confirmed via x-ray, and the implanting clinician did not coil the receiver during the implant procedure.The medical team believes that during the snowboarding accident, the device was pinched/cut between the lamina of the two vertebrae at the level of epidural entry.The neurostimulators associated with the complaint were returned for investigation.Results of the investigations are as follows: the investigation for rma-2024-11822 found circuit failure as the device was cut in half at the pcb and failed the automated functional test on stimulator verification unit (tf-0029).Additional visual inspection revealed evidence of liquid ingress (i.E.Efflorescence, oxidation) as well as damaged circuitry.The severe force applied to the implant caused the fractured neurostimulator, damaged circuitry, and liquid ingress.The investigation for rma-2024-11823 found the device failed the automated functional test on stimulator verification unit (tf-0029) due to circuit failure.The device was unable to power up as there was no outward current flow to the electrodes.Visual inspection revealed evidence of liquid ingress (i.E.Efflorescence, oxidation) as well as damaged circuitry.The severe force applied to the implant may have caused the liquid ingress and damaged circuitry.The stimulator is used to treat pain.The cause of loss of therapy, migration, and the fractured device is due to severe force applied to the implant (patient fall, accident) as the patient fell during a snowboarding accident (user error- patient).Additionally, inadequate fixation was identified as the implanting clinician did not coil the receiver during the implant procedure (user error- clinician).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 and increased pain after a snowboarding accident and migration was confirmed via x-ray.Attempts were made to change the transmitter settings with no success and an explant procedure was scheduled for (b)(6) 2024.During the explant procedure, one of the neurostimulators was removed without issue.However, the second device was broken off at the lamina and could not be completely explanted.The patient was referred to a neurosurgeon to perform a micro-laminotomy to remove the fragment of the device that remained implanted.On (b)(6) 2024, the remaining portion of the device was explanted.The patient is doing well and will be implanted with two new neurostimulators (date is unknown).

• 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: 20907617
• Report Number: 3010676138-2024-00269
• Device Sequence Number: 13056495
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: (01)00818225020693(17)210201(01)00818225020648(17)210201(21)209855-61
• 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: 2019
• Device Explanted Year: 2024
• 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): 02/21/2025

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: 02/01/2021
• Device Model Number: FR8A-RCV-A0, FR8A-SPR-B0
• Device Lot Number: SWO190222, SWO190225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male