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

Model Number FR8A-RCV-A0

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

Patient Problem Bacterial Infection (1735)

Event Date 10/26/2019

Event Type  Injury  

Manufacturer Narrative

Immediately following notification, stimwave quality and the agent reviewed events preceding the issue.The patient had a permanent procedure performed on (b)(6) 2019, in which one (1) stimulator receiver (fr8a-rcv-a0) was implanted at the t8-t9 vertebral level for back pain.The agent confirmed that the implant procedure was performed in a sterile environment, sterile field handling protocols were used, the procedure was completed in accordance with the product instructions for use, and the sterile barriers of all product used were intact prior to implant.The procedure was completed without complication, and the agent maintained contact with the patient following implant.On october 26, 2019, the patient contacted the implanting clinician to report drainage at the incision.Since the patient was out of town, the implanting clinician advised the patient to visit the emergency room (er).The patient was treated by a doctor and cultures of the site were taken.The results demonstrated the patient had a moderate staph infection at the implant site and low staph infection at the skin surrounding the implant site.The patient had antibiotics administrated (dosage and duration unknown) and scheduled an appointment with the implanting clinician.On (b)(6) 2019, the patient visited the implanting clinician's office.During the visit, the agent was notified of the infection.The implanting clinician made the decision to explant the device.The procedure was performed on (b)(6) 2019 and was completed without complications.The patient reported to be getting therapy from their device until the moment of implant.The agent reported the patient was of slim physiology.It is likely the patient was lacking enough tissue and the wound opened up, which subsequently contaminated the site and resulted in the confirmed infection.Infection is a known adverse event for spinal cord stimulation and the freedom scs system and is detailed in stimwave's risk management file as well as applicable instruction for use and patient-facing labeling.Stimwave's global infection rate is <0.5%.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 attributed to patient physiology.The patient did not have enough tissue to secure the device deep enough and the wound opened up due to stress from the device.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 constant contact with the agent from november 4, 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 attribute to patient physiology.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 this event required medical intervention by a health care professional to prevent or preclude potential permanent impairment or damage.Stimwave reported this issue to the united states food and drug administration (fda) on november 22, 2019.

Event Description

Stimwave quality has investigated the details regarding a complaint resulting from an infection reported to stimwave on november 4, 2019, by agent.

• 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: elizabeth greene ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 9365574
• MDR Text Key: 185490022
• Report Number: 3010676138-2019-00055
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: (01)00818225020693(17)210201
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2021
• Device Model Number: FR8A-RCV-A0
• Device Lot Number: SWO190202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2019
• 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