MAUDE Adverse Event Report: CURONIX LLC FREEDOM SPINAL CORD STIMULATOR

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

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

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/18/2023

Event Type  Injury  

Event Description

The patient reported loss of therapy and a broken implant.The patient has not used the therapy since 2020.However, multiple reprogramming attempts were made without success.The reported issue of broken implant has not been confirmed as x-rays have not been obtained.No additional information provided.

Manufacturer Narrative

The other adverse events issues questionnaire was completed by quality with limited information. potential causes of loss of therapy are severe force applied to the implant migration, improper stimulation parameters, improper placement during surgery, and patient contraindicating conditions.Potential causes of a broken implant are severe force or bending during implantation, improper surgical technique, and severe force applied to the implant.  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 other adverse events issues.Other adverse events issues rates remain acceptably low; thus, capa is not required.Other adverse events issues rates will continue to be tracked and trended.

Event Description

The patient reported loss of therapy and a broken implant.The patient has not used the therapy since 2020.However, multiple reprogramming attempts were made without success.The reported issue of broken implant has not been confirmed as x-rays have not been obtained.No additional information provided.

Manufacturer Narrative

The other adverse events issues questionnaire was completed by quality with limited information. potential causes of loss of therapy are severe force applied to the implant migration, improper stimulation parameters, improper placement during surgery, and patient contraindicating conditions.Potential causes of a broken implant are severe force or bending during implantation, improper surgical technique, and severe force applied to the implant.  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 other adverse events issues.Other adverse events issue rates remain acceptably low; thus, capa is not required.Other adverse events issue rates will continue to be tracked and trended.Updated per fda capa: 2023-0013.

• 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: 17757722
• MDR Text Key: 323526896
• Report Number: 3010676138-2023-00196
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020648
• UDI-Public: (01)00818225020648(17)200301(01)00818225020693(17)200401(21)208125-1
• 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,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2020
• Device Model Number: FR8A-SPR-B0, FR8A-RCV-A0
• Device Lot Number: SWO180322, SWO180417
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/02/2018
• 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