MAUDE Adverse Event Report: CURONIX LLC FREEDOM NEUROSTIMULATOR

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

Patient Problem Pain (1994)

Event Date 03/29/2022

Event Type  Injury  

Manufacturer Narrative

The unintended stimulation/new pain questionnaire was completed by quality with limited information. potential causes of pain are incorrect programming parameters, change in posture or proximity of electrode to target nerve resulting in stimulation of nerve outside the target nerve, interference from a non-curonix device, patient contraindicating conditions, and migration.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.Capa-2023-0001 was initiated to investigate and remediate the noncompliance to company reporting procedures.

Event Description

The patient reported burning sensation when bending, pain when stretching and severe wound pain.No additional information provided.Attempts to obtain additional information from the commercial team member were made with no success.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: FREEDOM NEUROSTIMULATOR
• 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: 17375988
• MDR Text Key: 319692202
• Report Number: 3010676138-2023-00138
• Device Sequence Number: 1
• Product Code: GZF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Report Date: 07/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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