MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM

Model Number FR8A-RCV-A0,FR8A-SPR-B0

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 11/23/2018

Event Type  Injury  

Manufacturer Narrative

Stimwave quality has investigated the details surrounding a complaint resulting from an infection reported to stimwave on december 5, 2018, by stimwave clinical specialist.Following a successful trial with the freedom spinal cord stimulator (scs) system, the patient had a permanent procedure performed on (b)(6) 2018, in which a freedom-8a receiver stimulator (fr8a-rcv-a0), freedom-8a spare lead (fr8a-spr-b0), and sandshark injectable anchor (sia) system (shrk-all-1k) were implanted in the patient's epidural space to treat the patient's low back and bilateral leg pain.There were no complications during the procedure, and patient reported receiving approximately 50% pain relief.The patient was discharged the same day.The implanting clinician prescribed one week of antibiotics (name and dose unknown) after the implant procedure.The patient met with the implanting clinician on (b)(6) 2018 to check the wound sites for healing and signs of infection, and did not identify any issues with the patient or the device.The patient reported insufficient pain relief with the device, and met with a clinical specialist for reprogramming on (b)(6) 2018.The clinical specialist noticed that the patient had new wound dressings, and the patient did not report any issues with the wound site or any other complications.The patient stated that she was more comfortable when she would apply the transmitting antenna directly on her skin, and was reminded that the wearable antenna assembly (waa) user manual's contains the following warning: waa skin contact - do not place the waa directly on the skin.Direct skin contact may cause irritation and/or sensitivity to the materials.The waa must be placed overtop a thin layer of clothing at all times.On (b)(6) 2018, the patient reported that she began experiencing discomfort and discharge at the surgical site, and went to a local emergency room for evaluation and treatment.The implanting clinician was contacted regarding the patient's status and consulted with the hospital's on-staff neurosurgeon and determined that device explant was necessary.The patient was admitted to the hospital on (b)(6) 2018 for iv antibiotics for two (2) days.On (b)(6) 2018, the patient's device was explanted.Pathology reports confirmed that the infection was staphylococcus.The patient was discharged on (b)(6) 2018 and was given a prescription of antibiotics (daptomycin, duration unknown) to complete at home.On (b)(6) 2018, the patient reported that she was feeling better, was no longer experiencing pain at the surgical site, and the wound sites had healed.The patient will continue to follow up with the implanting clinician.Immediately following notification, stimwave quality and management reviewed the procedure and after care with the clinical specialist present at the trial procedure.The clinical specialist confirmed that the procedure was performed in a sterile environment, sterile field handling protocols were used, the trial procedure was completed in accordance with the product instructions for use, and the sterile barriers of all product used were intact prior to implant.No complications arose during the implant procedure, and the implanting clinician prescribed antibiotics for the patient after the implant procedure.It is unknown if the patient complied with infection prevention practices after the implant procedure.To rule out any potential issues with product sterility, stimwave reviewed sterilization records on product from inventory, which confirmed the products from the same lots are sterile out of the package.The raw data from sterilization cycle matched the cycle specification.Stimwave quality, engineering, and manufacturing verified that the correct cycle specification was used for the stimulator lot.The source of the issue was not traced back to compromised product sterility or operating room conditions.The patient's personal hygiene and home environment are uncontrolled factors that may have contributed to the presentation of the infection.At this time, it is undetermined that the device caused or contributed to the issue.Surgical site infection is a known complication of surgery and is listed as a contraindication in the instructions for use.At this time, the source of the issue could not traced back to compromised product sterility or operating room conditions.The source of the issues is likely attributed to a lack of compliance to wound care practices at the patient's home environment, and noncompliance to written warnings about device usage.The device did not fail to meet performance or safety specifications during the procedure.Stimwave will continue to 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, nor nonconformance to physical or functional device specifications.The root cause is likely attributed to the patient's lack of compliance to wound care practices at the patient's home environment, or factors outside the control of stimwave and medical professionals.The stimwave product was not the source of the issue.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 product was delivered sterile, and the sterile barriers were not compromised.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 was in constant contact with the therapy specialist starting december 5, 2018, regarding the complaint and the root cause investigation.Stimwave confirmed that the product was provided sterile, did not fail to meet performance and safety specifications, and verified that the surgery center had demonstrated compliance with sterilizations standard for implantation procedures for treatment.The patient's lack of compliance to wound care practices may have contributed to the infection.Stimwave has informed all parties that the product was not the source of the 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 infection can be considered an injury, and medical or surgical intervention was required to preclude permanent impairment or damage.Stimwave has reported this as an adverse event to the united states food and drug administration (fda) on december 11, 2018.

Event Description

On (b)(6) 2018, the patient reported that she began experiencing discomfort and discharge at the surgical site, and went to a local emergency room for evaluation and treatment.The implanting clinician was contacted regarding the patient's status and consulted with the hospital's on-staff neurosurgeon and determined that device explant was necessary.The patient was admitted to the hospital on (b)(6) 2018 for iv antibiotics for two (2) days.On (b)(6) 2018, the patient's device was explanted.Pathology reports confirmed that the infection was staphylococcus.The patient was discharged on (b)(6) 2018 and was given a prescription of antibiotics (daptomycin, duration unknown) to complete at home.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FM 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
• MDR Report Key: 8158308
• MDR Text Key: 130168887
• Report Number: 3010676138-2018-00020
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020648
• UDI-Public: (01)00818225020648(17)200201(01)00818225020792(17)200201(21)207668-12
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180981
• 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: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2019
• Device Model Number: FR8A-RCV-A0,FR8A-SPR-B0
• Device Lot Number: SWO180215;SWO180206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/05/2018
• Device Age: 16 MO
• Event Location: Home
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2017
• 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): Hospitalization