MAUDE Adverse Event Report: CURONIX LLC FREEDOM SPINAL CORD STIMULATOR; TRANSMITTER ANTENNA

Device Problem Use of Device Problem (1670)

Patient Problems Discomfort (2330); Skin Inflammation/ Irritation (4545)

Event Date 08/23/2023

Event Type  Injury  

Manufacturer Narrative

The waa connectivity and antenna failure issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, it was determined the patient was wearing the antenna directly on the skin which is not compliant with the ifu.The stimulator is used to treat pain.The cause of the reported issue is due to non-compliance to the ifu as the patient was wearing the antenna directly on their skin (user error - patient).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in non-compliance to ifu.Non-compliance to ifu rates remain acceptably low; thus, capa is not required.Non-compliance to ifu rates will continue to be tracked and trended.

Event Description

The patient reported discomfort and irritation at the implant site where they wear the antenna.The patient disclosed wearing the antenna directly on the skin.Additionally, they are using lidocaine pads on their skin where the pad sits.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR
• Type of Device: TRANSMITTER ANTENNA
• 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: 17784211
• MDR Text Key: 323869048
• Report Number: 3010676138-2023-00199
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182720
• 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: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• 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: 08/23/2023
• 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
• Patient Sex: Female