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 12/21/2018

Event Type  Injury  

Manufacturer Narrative

Stimwave quality has investigated the details surrounding a complaint resulting from an infection reported to stimwave on (b)(6) 2018, by stimwave clinical specialist (b)(6).The patient had a permanent procedure performed on (b)(6) 2018, in which two freedom-8a stimulators (fr8a-rcv-a0 and fr8a-spr-b0) were implanted in the epidural space at the t8 to t9 level to treat lower back and lower leg pain.There were no complications during the implant procedure and the patient was receiving pain relief.Antibiotics were prescribed (name, dose and duration unknown) before and after the implant procedure, but patient compliance is unknown.At a follow-up appointment on (b)(6) 2018, the implanting clinician observed that the wound was healing and did not detect infection.The patient reported effective pain relief with the device, and did not report any other issues.On (b)(6) 2018, the patient met with stimwave clinical specialist (b)(6) for a reprogramming session.The patient informed the clinical specialist that she had a fever for approximately one (1) week, and had been to her primary car physician on (b)(6) 2018.The patient reported that the physician visually evaluated the incision site and prescribed antibiotics (type, dosage, duration unknown) for potential infection.When asked about the antibiotics, the patient stated that she had not pick up or started taking the antibiotics prescribed the previous day.The clinical specialist immediately informed the implanting clinician on the patient's state, and met with the patient to assess the incision site.As a precaution, the implanting clinician sent the patient to the emergency room and recommended explanted the device for the same day.The patient was treated for an infection at a local emergency room.The implanting clinician reported that upon opening the incision site and completing the explant, he did not observe any signs of infection, thus no cultures were taken for evaluation.The patient remained overnight in the hospital for treatment and was discharged on (b)(6) 2018.On (b)(6) 2018, that patient reported she that she had made a fully recovery fully from the explant and did not report any other issues.Immediately following notification by the clinical specialist on (b)(6) 2018, stimwave quality and management reviewed the implanting clinician's procedure compared to instructions for use.The clinical specialist confirmed that the 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.No complications arose during the implant procedure.It is unknown if the patient complied with infection prevention practices following the implant procedure, given that she was prescribed antibiotics on (b)(6) 2018, but had not started the treatment.The clinical specialist informed stimwave that the patient was diabetic.During explant, the clinician did not observe any signs of infection and did not order any cultures of the incision site.While the patient was treated in the hospital for a potential infection, the diagnosis is unconfirmed.Additional follow-up appointments and any additional antibiotics prescribed for the patient after the explant is unknown to stimwave.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.Surgical site infection is a known complication of surgery.The source of the issue is likely attributed to patient noncompliance with infection prevention practices after the implant procedure, and comorbidities that made the patient more susceptible to post-operative infections.Stimwave confirmed that the facility and implanting clinician followed infection prevention protocols to minimize the potential for infection with this patient.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, nor nonconformance to physical or functional device specifications.The root cause is likely attributed to the patient noncompliance to infection prevention practices, or the patient's personal hygiene or home environment.There is not enough information about the patient's home environment or personal hygiene or care to confirm the source of the issue.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 and mitigated as far as possible.Stimwave was in constant contact with the clinical specialist starting (b)(6) 2018, regarding the complaint and the root cause investigation.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.The issue is a known risk and is mitigated as far as possible.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 lead to 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) december 31, 2018.

Event Description

On (b)(6) 2018, the patient met with stimwave clinical specialist (b)(6) for a reprogramming session.The patient informed the clinical specialist that she had a fever for approximately one (1) week, and had been to her primary car physician on (b)(6) 2018.The patient reported that the physician visually evaluated the incision site and prescribed antibiotics (type, dosage, duration unknown) for potential infection.When asked about the antibiotics, the patient stated that she had not pick up or started taking the antibiotics prescribed the previous day.The clinical specialist immediately informed the implanting clinician on the patient's state, and met with the patient to assess the incision site.As a precaution, the implanting clinician sent the patient to the emergency room and recommended explanted the device for the same day.The patient was treated for an infection at a local emergency room.The implanting clinician reported that upon opening the incision site and completing the explant, he did not observe any signs of infection, thus no cultures were taken for evaluation.The patient remained overnight in the hospital for treatment and was discharged on (b)(6) 2018.On (b)(6) 2018, that patient reported she that she had made a full recovery from the explant and did not report any other issues.

• 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 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: 8207099
• MDR Text Key: 131789441
• Report Number: 3010676138-2018-00028
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00859619004975
• UDI-Public: (01)00859619004975(17)190801(01)00859619004905(17)191201(21)207254-72
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170141
• 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: 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• 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: SWO170828;SWO171206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/21/2018
• Device Age: 13 MO
• Event Location: Home
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention