MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number FR4A-TRL-B0

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 03/12/2024

Event Type  Injury  

Event Description

The commercial team member reported that the implanting clinician was unable to safely advance the introducer to implant the trial neurostimulator without moving/dragging surrounding tissue with it.The trial procedure was aborted.The patient received a nerve block and will search for other pain relief options.

Manufacturer Narrative

The other adverse events questionnaire was reviewed for potential causes of the reported issue.The implanting clinician stated that the reported issue was due to patient anatomy as the patient's skin was too loose which prevented the introducer from advancing.The stimulator is used to treat pain.The cause of the reported issue is due to the patient being a poor candidate due to health, weight, age, mental capacity as the patient's skin was too loose which prevented the introducer from advancing (user error-clinician).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, a capa is not required.Other adverse events issues rates will continue to be tracked and trended.

Event Description

The commercial team member reported that the implanting clinician was unable to safely advance the introducer to implant the trial neurostimulator without moving/dragging surrounding tissue with it.The trial procedure was aborted.The patient received a nerve block and will search for other pain relief options.

Manufacturer Narrative

The other adverse events questionnaire was reviewed for potential causes of the reported issue.The implanting clinician stated that the reported issue was due to patient anatomy as the patient's skin was too loose which prevented the introducer from advancing.The stimulator is used to treat pain.The cause of the reported issue is due to the patient being a poor candidate due to health, weight, age, mental capacity as the patient's skin was too loose which prevented the introducer from advancing (user error-clinician).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, a capa is not required.Other adverse events issues rates will continue to be tracked and trended.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Type of Device: PERIPHERAL NERVE STIMULATOR
• 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 boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 19056388
• MDR Text Key: 339548667
• Report Number: 3010676138-2024-00048
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00850051034383
• UDI-Public: (01)00850051034383(17)250801
• 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: 04/10/2024

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 Model Number: FR4A-TRL-B0
• Device Lot Number: SWO230807
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/13/2023
• 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: 89 YR
• Patient Sex: Male