MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number STQ4-RCV-A0

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

Patient Problem Pain (1994)

Event Date 05/23/2023

Event Type  Injury  

Manufacturer Narrative

The unintended stimulation/new pain questionnaire was completed by quality with limited information.Potential causes of pain and unintended stimulation are patient contraindicating conditions, improper placement during surgery, incorrect programming parameters, change in posture or proximity of electrode to target nerve resulting in stimulation of nerves outside the target nerve, stimulator electrical failure, interference from a non-curonix device, and interference from other electromagnetic sources.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 Description

The patient reported more pain in their thigh after getting the device implanted.Additionally, they reported they did not receive adequate relief following the procedure and found that the stimulation was too high.The device was reprogrammed several times and an explant procedure was performed on (b)(6) 2022.However, the exact date is unknown.

Manufacturer Narrative

The unintended stimulation/new pain questionnaire was completed by quality with limited information.Potential causes of pain and unintended stimulation are patient contraindicating conditions, improper placement during surgery, incorrect programming parameters, change in posture or proximity of electrode to target nerve resulting in stimulation of nerves outside the target nerve, stimulator electrical failure, interference from a non-curonix device, and interference from other electromagnetic sources.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 capa-2023-0013 correction 2.

Event Description

The patient reported more pain in their thigh after getting the device implanted.Additionally, they reported they did not receive adequate relief following the procedure and found that the stimulation was too high.The device was reprogrammed several times and an explant procedure was performed in october of 2022.However, the exact date is unknown.

• 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: 17173122
• MDR Text Key: 317629774
• Report Number: 3010676138-2023-00087
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: (01)00818225020464(17)230601
• 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 Expiration Date: 06/01/2023
• Device Model Number: STQ4-RCV-A0
• Device Lot Number: SWO210614
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 05/23/2023
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2021
• 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