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 Erosion (1750)

Event Date 11/16/2023

Event Type  Injury  

Event Description

The patient reported a furuncle that was adjacent to the lower level of where the receiver was implanted which caused erosion.The patient went to the emergency room where the furuncle was lanced and antibiotics were prescribed.While lancing the furuncle, the stimulator was cut and as a result, the patient experienced loss of therapy.At a later appointment, the implanting clinician met with the patient, opened the lower part of the pocket and found no infection, gently closed the incision, and prescribed additional antibiotics.Attempts to reprogram the transmitter assembly were made.However, they were unsuccessful.Additionally, an explant procedure is planned.A date is not yet scheduled.

Manufacturer Narrative

The loss of therapy/no therapy issues questionnaire was reviewed for potential causes of the reported issue.Based on this review, not achieving therapy, implanting the device at an off-label location, not performing an x-ray immediately after the procedure to confirm placement, and attempts to reprogram the waa have been ruled out as potential causes.Other potential causes of erosion are inadequate fixation, severe force applied to implant, excessive twisting or stretching, inappropriate device positioning, patient non-compliance (touching or picking at the wound), and patient contraindicating conditions.The clinical representative confirmed the device was properly fixated at the time of the implant.A curonix representative conducted a review of sterilization and packaging records for the respective product lot; curonix has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.The stimulator is used to treat pain.The investigation findings do not lead to a clear conclusion about the cause of the reported issue.Therefore, the conclusion has been selected as unable to determine the 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.

• 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: 18341109
• MDR Text Key: 330659972
• Report Number: 3010676138-2023-00267
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020648
• UDI-Public: (01)00818225020648(17)200801(01)00859619004875(17)191001(21)26907-61
• 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
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2020
• Device Model Number: FR8A-SPR-B0, FR8A-RCV-A0
• Device Lot Number: SWO180815, SWO171024
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2018
• 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 Outcome(s): Required Intervention
• Patient Sex: Female