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 Chest Pain (1776)

Event Date 09/21/2022

Event Type  Injury  

Manufacturer Narrative

The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, the script was completed with limited information.Based on this review, the stimulator being implanted in an off-label location was ruled out as a potential cause.The senior manager, clinical research reported this event is not related to the stimwave device.The stimulator is used to treat pain.The cause of the reported issue is unknown.The provided information does not evidence that the stimwave device contributed to the issue.Investigation conclusion has been attributed to clinician user error due to improper patient selection/inadequate evaluation of pre-existing conditions prior to implant.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in other adverse events issues.Other adverse events issues rates remain acceptably low; thus, capa is not required. other adverse events issues rates will continue to be tracked and trended.

Event Description

A freedom-1 clinical study patient was admitted to the hospital due to shortness of breath and chest pain.They were diagnosed with blood clots.The patient was prescribed eloquis and will have a ct scan performed in the next two weeks to monitor the blood clots.Additionally, the patient is diabetic, has high cholesterol, and high blood pressure.The patient has been caring for their spouse which caused edema.Water pills were prescribed for this condition.

• 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
• MDR Report Key: 15722331
• MDR Text Key: 303034371
• Report Number: 3010676138-2022-00133
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: (01)00818225020464(17)230401
• 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: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2023
• Device Model Number: STQ4-RCV-A0
• Device Lot Number: SWO210407
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2021
• 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
• Patient Outcome(s): Required Intervention