MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR; WEARABLE ACCESSORY

Lot Number 00-52004

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

Patient Problems Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 02/26/2024

Event Type  Injury  

Event Description

The patient reported blisters forming on their leg under the wearable.The patient stated that the original blister healed after a couple days of not using the wearable.However, new blisters (in a new area) returned following re-initiating use of the wearable after the original blister had healed.The blister/ irritated skin area is not located near antenna or pocket used to store remote.The clinical representative instructed the patient to assure that the wearable is positioned tightly to avoid slipping or rubbing.Additionally, the clinical representative instructed the patient to wear a thin, minimal sleeve between the wearable and their skin to prevent possible future irritation.The patient has been provided a different breathable shin guard sleeve to use when running with the device that works well.No further issues have been reported.

Manufacturer Narrative

The wearable questionnaire was reviewed for potential causes of the reported issue.Potential causes of the reported issue are patient contraindicating conditions and incorrectly sized wearable.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 wearable issues.Wearable issue rates remain acceptably low; thus, a capa is not required at this time.Wearable issue rates will continue to be tracked and trended.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Type of Device: WEARABLE ACCESSORY
• Manufacturer (Section D): CURONIX LLC; 1310 park central blvd s; pompano beach FL 33064
• Manufacturer (Section G): CURONIX LLC; 1310 park central blvd s; pompano beach FL 33064
• Manufacturer Contact: tena jimmerson ; 1310 park central blvd s; pompano beach, FL 33064
• MDR Report Key: 19048985
• MDR Text Key: 339433648
• Report Number: 3010676138-2024-00043
• Device Sequence Number: 1
• Product Code: GZF
• 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
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 00-52004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 86 YR
• Patient Sex: Male