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

Model Number FR8A-TRL-A0

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2023

Event Type  Injury  

Manufacturer Narrative

The surgical issue questionnaire was reviewed for potential causes of the reported issue.The clinical representative did not notice the expiration date and (b)(4) was opened to investigate the expired product being implanted.A representative conducted a review of sterilization and packaging records for the respective product lot; it has been 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 implanting an expired product is due to the clinical representative providing the clinician with an expired trial stimulator (user error - clinical representative).Refer to (b)(4) for investigation details, including risk assessment of implanting an expired stimulator.

Event Description

An expired freedom scs neurostimulator trial lead was implanted.The product was shipped to the clinical representative on june 18, 2021, expired on march 01, 2023 and was implanted on (b)(6) 2023.The lead pull was performed as expected on (b)(6) 2023.The patient had a successful trial with no adverse events reported, and will be moving forward with a permanent implant.

• 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: 16709729
• MDR Text Key: 312985223
• Report Number: 3010676138-2023-00044
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020679
• UDI-Public: (01)00818225020679(17)230301
• 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: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2023
• Device Model Number: FR8A-TRL-A0
• Device Lot Number: SWO210301
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• 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