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

Model Number FR8A-RCV-A0

Device Problem Expulsion (2933)

Patient Problem Tissue Damage (2104)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

Immediately following notification, stimwave quality and the territory manager reviewed the events preceding the issue.The patient had a permanent procedure performed on (b)(6) 2019, in which one (1) freedom-8a receiver stimulator (fr8a-rcv-a0) and one (1) spare lead (fr8a-spr-b0) were implanted at the t8-t9 vertebral level.The territory manager confirmed that the implant procedures were performed in a sterile environment, sterile field handling protocols were used, the procedures were completed in accordance with the product instructions for use, and the sterile barriers of all product used were intact prior to implant.The procedures were completed without complications, and the territory manager maintained contact with the patient following implant.On an unknown date, the patient experienced a skin reaction at the implant site.The patient elected to visit a dermatologist and did not notify their implanting clinician.The dermatologist removed the surface of the skin that was affected.The patient was sent home the same day.On (b)(6) 2019, the patient attended a follow up visit with their implanting clinician and the territory manager.The territory manager noticed the mid-section of the patient's device was protruding through the skin where the patient's skin reaction had been prior.The implanting clinician did not observe any drainage or signs of infection.However, the decision was made to prophylactically explant the device that was exposed.The patient's second device remains implanted.The territory manager and the implanting clinician elected to turn off the device and wait for the patient's wound to heal before reprogramming the patient.No further complications were reported.The root cause of the issue cannot be traced to the device.The patient reported to be receiving therapy up until the moment the device was explanted.Device erosion is a known adverse event of spinal cord stimulators and the freedom scs system that is mitigated as far as possible in the product's risk management file.The source of the issue cannot be traced back to the device or procedure.The device did not fail to meet performance or safety specifications.Stimwave will continue to track and trend events.The root cause of the complaint is not attributed to device failure, the inability of the device to meet performance or safety specifications, or nonconformance to physical or functional device specifications.The stimwave product was not the source of the issue.The root cause of the issue is related to the treatment for the patient's skin reaction.The surface of the implant location was thinner due to the patient's treatment of the skin rection which subsequently lead to the patient's device erosion.Corrective action is not required to remedy the root cause of the complaint.The device did not fail to meet performance or safety specifications.Stimwave has confirmed that the issue is a known adverse event, mitigated as far as possible, and documented in the stimwave risk management file.Stimwave was in frequent contact with the territory manager from november 20, 2019, onward regarding the complaint and the root cause investigation.Stimwave confirmed that the product did not fail to meet performance and safety specifications.The source of the issue is attributed to patient's skin reaction.Stimwave has informed all parties that the product was not the source issue.In compliance with medical device reporting requirements and responsibilities, stimwave quality and its chief medical officer have determined that this issue is considered reportable as the event required medical or surgical intervention to prevent or preclude permanent impairment or damage.This event was reported to the united states food and drug administration (fda) on december 18, 2019.

Event Description

Stimwave quality has investigated the details regarding a complaint resulting from a device erosion reported to stimwave on november 20, 2019.

• 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: mary ann greenawalt ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 9492314
• MDR Text Key: 186602631
• Report Number: 3010676138-2019-00066
• Device Sequence Number: 1
• Product Code: GZB
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FR8A-RCV-A0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: No
• 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