MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM SPINAL CORD STIMULATOR

Model Number FR8A-TRL-B0, FR8A-TRL-A0

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

Patient Problems Purulent Discharge (1812); Burning Sensation (2146); Skin Infection (4544)

Event Date 04/01/2023

Event Type  Injury  

Manufacturer Narrative

The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, the script was completed with limited information.Potential causes of infection are patient non-compliance/touching or picking at the wound, implanting a non-sterile device, not irrigating the site with antibiotic solution, not using antibiotics pre-operatively, not implanting in a sterile field, not prepping the skin with antiseptic solution, multiple tunneling attempts and patient contraindications.However, sterile dressings were not placed on top of the open wound and the antenna was taped directly on the patient's back.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 infection is due to non-compliance to the ifu as a sterile dressing was not applied and the antenna was taped directly on the skin (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 Description

The patient reported redness, pus and burning at the surgical site.Infection was confirmed, a clean dressing was applied and antibiotics were prescribed.The leads were removed on (b)(6) 2023.The patient is currently doing well and no further issues have been reported.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 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: 16840104
• MDR Text Key: 314268480
• Report Number: 3010676138-2023-00057
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020662
• UDI-Public: (01)00818225020662(17)240401(01)00818225020679(17)240101(21)2B13956-99
• 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: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2024
• Device Model Number: FR8A-TRL-B0, FR8A-TRL-A0
• Device Lot Number: SWO220428, SWO220118
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• 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 Age: 76 YR
• Patient Sex: Female