MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number STQ4-RCV-A0

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

Patient Problem Pain (1994)

Event Date 03/01/2023

Event Type  Injury  

Manufacturer Narrative

The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device after the expiration date, not prepping the skin with antiseptic solution, not using antibiotics pre-operatively, using inappropriate tools, and multiple tunneling attempts have been ruled out as potential causes.Additionally, the site was irrigated with antibiotic solution before closure.Due to the extreme tenderness, the patient requested an explant procedure.The implanting clinician believes the pain was caused by the stitch around the lead as it was near the wrist and the patient was thin.A stimwave representative conducted a review of sterilization and packaging records for the respective product lot; stimwave 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 pain and tenderness is due to the patient being a poor candidate due to health, weight, age, or mental capacity as the patient is thin (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 pain and tenderness around both incisions.No infection was present.While wearing the antenna provided adequate relief, the patient was not able to wear it for long periods of time because of the tenderness.An explant procedure was performed on (b)(6) 2023.However, the patient still has tenderness around their incisions post explant.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Type of Device: PERIPHERAL NERVE 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: 16640042
• MDR Text Key: 312284921
• Report Number: 3010676138-2023-00040
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: (01)00818225020464(17)240701
• 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
• Report Date: 03/29/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: STQ4-RCV-A0
• Device Lot Number: SWO220726
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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