MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES FREEDOM

Device Problems Device Operates Differently Than Expected (2913); Material Protrusion/Extrusion (2979)

Patient Problems Erythema (1840); No Code Available (3191)

Event Date 01/21/2018

Event Type  Injury  

Event Description

On (b)(6) 2017, i had a stimwave system implanted in (b)(6) by dr.(b)(6).It only worked for about 2 weeks and then stopped providing pain relief.I tried calling the corporate headquarters several times, but got no response.On (b)(6) 2018, a red spot developed on my skin on my back and a wire was visible.I had a family member pull it out and contacted a company engineer to inform of the problem.I have been informed by my physician to explant system as a spinal cord infection might develope.My procedure was scheduled for me due to the urgency of the matter.

• Brand Name: FREEDOM
• Type of Device: FREEDOM
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES
• MDR Report Key: 7221415
• MDR Text Key: 98528153
• Report Number: MW5074879
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Weight: 77