MAUDE Adverse Event Report: CURONIX LLC FREEDOM SPINAL CORD STIMULATOR

Model Number	FR8A-RCV-A0
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting an expired stimulator, not prepping the skin with antiseptic solution, not prescribing antibiotics pre-operatively, and the patient not attending the post-op visit have been ruled out as potential causes.The doctor suspects the pocket site needs to be revised as the coil was implanted superficially.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 cause of the reported issue is due to incorrect surgical technique as the coil was implanted superficially (user error - clinician).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in surgical issues.Surgical issue rates remain acceptably low; thus, capa is not required. surgical issue rates will continue to be tracked and trended.
Event or Problem Description
The patient reported tenderness and occasional swelling at the receiver/pocket site.The doctor does not think there is an infection.The patient is wearing the device and getting relief.However, a revision procedure is scheduled for (b)(6) 2023.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR
• Common Device Name: 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: 17996658
• Report Number: 3010676138-2023-00221
• Device Sequence Number: 5884229
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: (01)00818225020693(17)230901
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K182720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/01/2023
• Device Model Number: FR8A-RCV-A0
• Device Lot Number: SWO210910
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Unknown