MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-RCV-A0, STQ4-SPR-B0
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported hip pain and migration of the left side neurostimulator was confirmed via x-ray.Attempts were made to reprogram the transmitter with no success.The patient would like to have a revision procedure as the device did work previously.Although slight migration was confirmed on the right neurostimulator, the patient is still getting good pain relief on the current programs.The patient is waiting to hear from a physician regarding the revision procedure.
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 at an off-label location, not performing an x-ray immediately after the procedure to confirm placement, inadequate fixation, improperly securing the neurostimulator at the insertion site, and no attempts to reprogram the transmitter have been ruled out as potential causes.Additionally, severe force applied to the implant, excessive twisting, bending or stretching, and contraindicating conditions have been ruled out.However, migration was confirmed via x-ray.The stimulator is used to treat pain.The cause of the hip pain is due to migration.However, the cause of the migration is unknown.The investigation findings do not lead to a clear conclusion about the cause of migration.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, 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 hip pain and migration of the left side neurostimulator was confirmed via x-ray.Attempts were made to reprogram the transmitter with no success.The patient would like to have a revision procedure as the device did work previously.Although slight migration was confirmed on the right neurostimulator, the patient is still getting good pain relief on the current programs.The patient is waiting to hear from a physician regarding the revision procedure.Additional information was received on june 5, 2024.An explant procedure was performed on (b)(6) 2024 and new neurostimulators were implanted.The patient is doing well.
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 at an off-label location, not performing an x-ray immediately after the procedure to confirm placement, inadequate fixation, improperly securing the neurostimulator at the insertion site, and no attempts to reprogram the transmitter have been ruled out as potential causes.Additionally, severe force applied to the implant, excessive twisting, bending or stretching, and contraindicating conditions have been ruled out.However, migration was confirmed via x-ray.The stimulator is used to treat pain.The cause of the hip pain is due to migration.However, the cause of the migration is unknown.The investigation findings do not lead to a clear conclusion about the cause of migration.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, a capa is not required at this time.Loss of therapy/no therapy issue rates will continue to be tracked and trended.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Common Device Name: PERIPHERAL NERVE 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: 19390364
• Report Number: 3010676138-2024-00095
• Device Sequence Number: 7799866
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: (01)00818225020464(17)221001(01)00818225020495(17)221201(21)2B12590-108
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 06/14/2024

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: 10/01/2022
• Device Model Number: STQ4-RCV-A0, STQ4-SPR-B0
• Device Lot Number: SWO201025, SW0201220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male