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

Model Number STQ4-RCV-A0, STQ4-SPR-B0

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

Patient Problem Pain (1994)

Event Date 02/21/2023

Event Type  Injury  

Manufacturer Narrative

The other adverse events issues questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device at an off-label location has been ruled out as a potential cause of the reported issue.Additionally, migration did not occur and the physician thought the lumps were normal.However, the device was reprogrammed and the patient's pain level decreased and therapy is working.The stimulator is used to treat pain.The cause of the lumps is unknown.However, the cause of the pain is due to incorrect programming parameters (user error - clinical representative).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

The patient reported lumps on their back.Additionally, on (b)(6) 2023 the patient reported it felt like the leads grab on something if they moved a certain way, increasing their pain.The physician thought the lumps were normal.The device was reprogrammed and the patient's pain level decreased.

• 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: 16801609
• MDR Text Key: 313897778
• Report Number: 3010676138-2023-00053
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: (01)00818225020464(17)240701(01)00818225020495(17)240701(21)2B15449-68
• 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: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• 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, STQ4-SPR-B0
• Device Lot Number: SWO220726, SWO220726
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2023
• 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