MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-SPR-B0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The no therapy/loss of therapy questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device at an off-label location and no attempts to reprogram the waa have been ruled out as potential causes.Additionally, the patient did not engage in activities with excessive twisting or bending and did not experience a fall.However, the questionnaire shows the clinician did not create subcutaneous receiver pocket, tie knots, coil receiver, and knot around the coil.It was confirmed that the only method utilized for securing the lead into the tissue was suturing.A curonix representative conducted a review of sterilization and packaging records for the respective product lot; curonix has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.The stimulator is used to treat pain.The cause of loss of therapy is migration.However, the cause of the migration is due to inadequate fixation as the clinician did not create subcutaneous receiver pocket, tie knots, coil receiver, and knot around the coil (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 a loss of therapy and migration was confirmed via x-ray.On (b)(6) , 2023, it was reported that the migration resulted in the skin being pierced from the inside out which caused new pain and signs of erosion.The patient reported that the pain area was red and very painful but the skin was not punctured.An explant procedure was performed on (b)(6) 2023.No additional issues have been reported.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Common Device Name: PERIPHERAL NERVE 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: 17961358
• Report Number: 3010676138-2023-00216
• Device Sequence Number: 4958639
• Product Code: GZF
• UDI-Device Identifier: 00818225020495
• UDI-Public: (01)00818225020495(17)240701
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 10/18/2023

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: 07/01/2024
• Device Model Number: STQ4-SPR-B0
• Device Lot Number: SWO220726
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• 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: Unknown