MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number STQ4-SPR-B0, STQ4-RCV-A0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 05/16/2023

Event Type  Injury  

Event Description

The patient reported extreme pain immediately after surgery, whether the device was on or off.As a result, they requested the device be explanted.An explant procedure was performed on (b)(6) 2023 and no further issues were reported.

Manufacturer Narrative

The other adverse events issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, the incident occurring before the device was implanted, implanting the device at an off-label location, and using the waa when the incident happened have been ruled out as potential causes.Additional potential causes are improper placement during surgery, incorrect surgical technique and patient contraindicating conditions.The implant procedure was performed following the instructions for use.The cause of the pain is unknown.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 the explant is due to extreme pain.However, the cause of the pain 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 other adverse events issues.Other adverse events issues rates remain acceptably low; thus, capa is not required.Other adverse events issues rates will continue to be tracked and trended.

Event Description

The patient reported extreme pain immediately after surgery, whether the device was on or off.As a result, they requested the device be explanted.An explant procedure was performed on(b)(6) 2023 and no further issues were reported.

Manufacturer Narrative

The other adverse events issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, the incident occurring before the device was implanted, implanting the device at an off-label location, and using the waa when the incident happened have been ruled out as potential causes.Additional potential causes are improper placement during surgery, incorrect surgical technique and patient contraindicating conditions.The implant procedure was performed following the instructions for use.The cause of the pain is unknown.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 the pain 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 other adverse events issues.Other adverse events issue rates remain acceptably low; thus, capa is not required.Other adverse events issue rates will continue to be tracked and trended.Updated per fda capa(b)(4)correction 2.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Type of Device: 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: 17111447
• MDR Text Key: 317032247
• Report Number: 3010676138-2023-00078
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020495
• UDI-Public: (01)00818225020495(17)240701(01)00818225020464(17)241001(21)2B16172-18
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: STQ4-SPR-B0, STQ4-RCV-A0
• Device Lot Number: SWO220726, SWO100522
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/12/2023
• Supplement Dates Manufacturer Received: 05/16/2023
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female