MAUDE Adverse Event Report: CURONIX LLC FREEDOM SPINAL CORD STIMULATOR

Model Number FR8A-RCV-A0, FR8A-SPR-B0

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

Patient Problem Electric Shock (2554)

Event Date 08/04/2023

Event Type  Injury  

Event Description

The patient reported feeling extreme heating during two mri procedures.The procedures were aborted and the patient reported the same feeling five hours following the procedures.The clinical representative confirmed the mri guidelines were followed during the mri scans.

Manufacturer Narrative

The issues after an mri questionnaire was reviewed for potential causes of the reported issue.Based on this review, not aborting the mri procedure, the mri facility not following ifu for mri, the patient experiencing a fall, injury, or engaging in strenuous activities since the implant, the patient having any other implanted pins, screws, devices, and migration has been ruled out.The clinical representative confirmed the wearable device was left in the car, and x-rays have not been performed following the mri to confirm device placement.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 issues after an mri issues.Issues after an mri issue rates remain acceptably low; thus, capa is not required. issues after an mri issue rates will continue to be tracked and trended.

Event Description

The patient reported feeling extreme heating during two mri procedures.The procedures were aborted and the patient reported the same feeling five hours following the procedures.The clinical representative confirmed the mri guidelines were followed during the mri scans.As of september 1, 2023, the patient seems to be ok, with no lasting symptoms.

Manufacturer Narrative

The issues after an mri questionnaire was reviewed for potential causes of the reported issue.Based on this review, not aborting the mri procedure, the mri facility not following ifu for mri, the patient experiencing a fall, injury, or engaging in strenuous activities since the implant, the patient having any other implanted pins, screws, devices, and migration has been ruled out.The clinical representative confirmed the wearable device was left in the car, and x-rays have not been performed following the mri to confirm device placement.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 issues after an mri issues.Issues after an mri issue rates remain acceptably low; thus, capa is not required. issues after an mri issue rates will continue to be tracked and trended.

Event Description

The patient reported feeling extreme heating during two mri procedures.The procedures were aborted and the patient reported the same feeling five hours following the procedures.The clinical representative confirmed the mri guidelines were followed during the mri scans.As of (b)(6)2023, the patient seems to be ok, with no lasting symptoms.

Manufacturer Narrative

The issues after an mri questionnaire was reviewed for potential causes of the reported issue.Based on this review, not aborting the mri procedure, the mri facility not following ifu for mri, the patient experiencing a fall, injury, or engaging in strenuous activities since the implant, the patient having any other implanted pins, screws, devices, and migration has been ruled out.The clinical representative confirmed the wearable device was left in the car, and x-rays have not been performed following the mri to confirm device placement.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 issues after an mri issues.Issues after an mri issue rates remain acceptably low; thus, capa is not required. issues after an mri issue rates will continue to be tracked and trended.Updated per fda capa(b)(4)correction 2.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR
• Type of Device: SPINAL CORD 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: 17672969
• MDR Text Key: 322537728
• Report Number: 3010676138-2023-00181
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00859619004073
• UDI-Public: (01)00859619004073(17)191001(01)00859619004783(17)200201(21)207613-26
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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,Followup,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2019
• Device Model Number: FR8A-RCV-A0, FR8A-SPR-B0
• Device Lot Number: SWO171023, SWO180215
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2017
• 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