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 12/05/2018

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.The patient had a trial procedure performed on (b)(6) 2018, in which two freedom-8a trial leads (fr8a-trl-a0 and fr8a-trl-b0) were implanted bilaterally at the t8-t9 and t9-t10 vertebrae to treat the patient's lower back and radicular (right leg) pain.There were no complications during the implant procedure.According to the implanting hospital's protocol for scs trial procedures, antibiotic prophylaxis (specific type unknown) was administered either through intramuscular or iv.The patient was prescribed oral antibiotics (keflex, 500mg three (3) times per day) throughout the entirety of the trial implant period.Patient compliance with the prescribed antibiotic is unknown.The clinical specialist maintained contact with the patient following implant.The patient reported 20% leg pain relief and no reduction in lower back pain throughout the trial period.The patient refused the clinical specialist's offers to meet for assessment and reprogramming.Additionally, against post-operative instructions to not shower or wet the implant site, the patient reported removing the bandage, applying a waterproof bandage, and showering.Upon examination of the patient at the explant procedure on (b)(6) 2018, the nurse noted possible infection at the lead entry and suture sites.Additional antibiotics (type, dosage, and duration unknown) were prescribed on the day of explant.Additionally, one (1) stimulator was noted to have migrated cephalad, with only the knotted end remaining outside of the entry point.Both stimulators were explanted without complication.The antibiotic prescription provided at the start of the trial was extended (duration unknown).Immediately following notification, stimwave quality and management reviewed the implanting clinician's procedure compared to the trial instructions for use with the clinical specialist.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.To confirm device sterility, stimwave quality investigated the sterilization records for the applicable stimulator lots.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.Surgical site infection is a known complication of surgery and is listed as a contraindication in the instructions for use.The source of the issues is likely resultant of patient noncompliance to post-operative instructions, specifically showering and removing or changing wound dressings.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 patient noncompliance to post-operative care instructions.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 source of the issue is a known risk and is mitigated as far as possible.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 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.

Event Description

Upon examination of the patient at the explant procedure on (b)(6) 2018, the nurse noted possible infection at the lead entry and suture sites.Additional antibiotics (type, dosage, and duration unknown) were prescribed on the day of explant.Additionally, one (1) stimulator was noted to have migrated cephalad, with only the knotted end remaining outside of the entry point.Both stimulators were explanted without complication.The antibiotic prescription provided at the start of the trial was extended (duration unknown).

• 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: 8160166
• MDR Text Key: 130219647
• Report Number: 3010676138-2018-00022
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020679
• UDI-Public: (01)00818225020679(17)200401(01)00818225020662(17)200901(21)209061-8
• 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: 12/13/2018

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: No Information
• Device Expiration Date: 04/01/2020
• Device Model Number: FR8A-RCV-A0;FR8A-SPR-B0
• Device Lot Number: SWO180404;SWO180919
• 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: 8 MO
• Event Location: Home
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2018
• 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