MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number STQ4-RCV-A0, STQ4-SPR-B0

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 10/23/2023

Event Type  Injury  

Event Description

The patient reported pain and their implant was shattered and is in pieces.An explant procedure is planned for next summer.The clinical representative has made multiple unsuccessful attempts to establish communication with the patient for the purpose of obtaining additional information.No additional information was provided.

Manufacturer Narrative

The perm - loss of therapy/no therapy issues questionnaire was completed with limited information.Potential causes of fractured stimulator are severe force applied to implant (patient fall/accident), severe force or bending during implantation, improper surgical technique, manufacturing issue, excessive pressure on the electrode array, and using incorrect tools at the time of the implant.The stimulator is used to treat pain.The cause of the reported issue is unknown.Therefore, the 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 loss of therapy/no therapy issues.Loss of therapy/no therapy issue rates remain acceptably low; thus, capa is not required. loss of therapy/no therapy issue rates will continue to be tracked and trended.

Event Description

The patient reported pain and their implant was shattered and is in pieces.The patient noted a ct scan was performed which revealed a shattered lead.An explant procedure is planned for next summer.However, a date was not provided.No further information was provided.

Manufacturer Narrative

The perm - loss of therapy/no therapy issues questionnaire was completed with limited information.Potential causes of fractured stimulator are severe force applied to implant (patient fall/accident), severe force or bending during implantation, improper surgical technique, manufacturing issue, excessive pressure on the electrode array, and using incorrect tools at the time of 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 loss of therapy/no therapy issues.Loss of therapy/no therapy issue rates remain acceptably low; thus, capa is not required. loss of therapy/no therapy issue rates will continue to be tracked and trended.Updated per fda capa-2023-0013 correction 2.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Type of Device: PERIPHERAL NERVE 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: 18172807
• MDR Text Key: 328560022
• Report Number: 3010676138-2023-00240
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: (01)00818225020464(17)230401(01)00818225020495(17)230401(21)2B12871-15
• 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: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2023
• Device Model Number: STQ4-RCV-A0, STQ4-SPR-B0
• Device Lot Number: SWO210408, SWO210429
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2021
• 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: 55 YR