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

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

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Erosion (2075)

Event Date 11/15/2018

Event Type  Injury  

Manufacturer Narrative

Stimwave quality has investigated the details surrounding a complaint resulting from device erosion through the skin reported to stimwave on (b)(6) 2018, by stimwave clinical specialist (b)(4).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 epidural space at the t8 to t9 level to treat the patient's low back and leg pain.There were no complications during the procedure.The patient experienced pain relief after the procedure and antibiotics were prescribed for the patient.On (b)(6) 2018, the patient met with the implanting clinician for a post-operative follow-up appointment and reported good pain relief with the device.The implanting clinician checked the incision sites, and did not observe any signs of complication or infection.On (b)(6) 2018, the patient contacted the implanting clinician and stated that the device was protruding from his skin and was causing some pain.The patient reported that he continued to receive good pain relief with the device, and a follow-up appointment scheduled to revise the stimulator.The implanting clinician met with the patient the same day and confirmed that the spare lead had eroded through the patients skin, but was not causing any pain.Thus, on (b)(6) 2018, the implanting clinician revised the spare lead by secured the proximal end into the subcutaneous tissue.The revised incision was closed with sutures.The implanting clinician did not identify any infection.The patient reported good pain relief with the device and reported no other complications or issues.The implanting clinician did not prescribe additional antibiotics at this appointment as the patient was continuing his initial prescription from the implant procedure.On (b)(6) 2018, the patient began to experience pain and went to an urgent care for evaluation.The medical professionals suspected that the patient had an infection and prescribed antibiotics (name, dose, and duration is unknown).Following this appointment, the patient contacted the implanting clinician to inform him of this visit.The implanting clinician asked the patient to come into the office for evaluation.The implanting clinician again checked the incisions sites, and determined that the revision was too superficial.To prevent any future issues with the device, the implanting clinician obtained the patient's consent to revise the device, by securing the proximal end deeper into the fascia.The implanting clinician did not prescribe any additional antibiotics as the patient had received a new prescription "form" urgent care.On (b)(6) 2018, the clinical specialist followed up with the patient and observed that the incision sites had fully healed and he was no longer experiencing the pain that sent him to urgent care.The patient reported that he continued to receive good pain relief with the device.Immediately following notification, stimwave quality and management reviewed the implanting clinician's procedure compared to the receiver instructions for use with the clinical specialist.The clinical specialist confirmed that the procedure was performed in accordance with the product instructions for use.No complications arose during the implant procedure.The procedure for fixating the receiver in the receiver instruction for use states that the device is to be anchored beneath the subcutaneous layer as deep as possible to prevent erosion through fat and skin layers (05-00629-2, page 23, k170141).It is likely that the implanting clinician technique for this step of the ifu did not secure the stimulator deep enough, which lead to the eventual device erosion through the skin.This is a known risk for the freedom scs system and had been migrated as far as possible by the revision to the ifu, which detail the steps for coiling the receiver and securing the to the fascia at three locations (05-00629-5, page 19, k180981).At the time of the patient's permanent procedure, this revision of the ifu was not available.The source of the issue was not traced back to inadequate documentation of implant procedure, and the device did not fail to meet performance or safety specifications.The patient is continuing use of the device and is receiving good pain relief.Stimwave will continue to trend events.It is worth noting that the implanting clinician has performed additional procedures since this issue, and he has not experienced any new cases of lead erosion or infection.The unconfirmed infection is secondary to the device erosion.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 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.The clinician prescribed antibiotics for the patient to take for infection prevention.The source of the issue was not traced back to compromised product sterility or operating room conditions.While surgical site infection is a known complication of surgery and is listed as a contraindication in the instructions for use, no pathology reports were completed to confirm an infection.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.However, it is likely attributed to a lack of compliance to wound care practices at the patient's home environment.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 that the physician's technique did not anchor the receiver deep enough into the subcutaneous receiver pocket.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 issue is a known risk, mitigated as far as possible, and documented in the stimwave's risk management file.Stimwave was in constant contact with the clinical specialist starting (b)(6) 2018, regarding the complaint and the root cause investigation.Stimwave confirmed that the implant procedure was performed according to the ifu, and the product did not fail to meet performance and safety specifications.The source of the issue has been mitigated by the revision to the ifu, which details the steps for fixating the receiver to the fascia.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 erosion of the device through the skin 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

On (b)(6) 2018, the patient contacted the implanting clinician and stated that the device was protruding from his skin and was causing some pain.The patient reported that he continued to receive good pain relief with the device, and a follow-up appointment scheduled to revise the stimulator.The implanting clinician met with the patient the same day and confirmed that the spare lead had eroded through the patients skin, but was not causing any pain.Thus, on (b)(6) 2018, the implanting clinician revised the spare lead by "secured" the proximal end into the subcutaneous tissue.The revised incision was closed with sutures.The implanting clinician did not identify any infection.The patient reported good pain relief with the device and reported no other complications or issues.The implanting clinician did not prescribe additional antibiotics at this appointment as the patient was continuing his initial prescription from the implant procedure.On (b)(6) 2018, the patient began to experience pain and went to an urgent care for evaluation.The medical professionals suspected that the patient had an infection and prescribed antibiotics (name, dose, and duration is unknown).Following this appointment, the patient contacted the implanting clinician to inform him of this visit.The implanting clinician asked the patient to come into the office for evaluation.The implanting clinician again checked the incisions sites, and determined that the revision was too superficial.To prevent any future issues with the device, the implanting clinician obtained the patient's consent to revise the device, by securing the proximal end deeper into the fascia.The implanting clinician did not prescribe any additional antibiotics as the patient had received a new prescription "form" urgent care.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer Contact: elizabeth grene ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 8119989
• MDR Text Key: 128901867
• Report Number: 3010676138-2018-00016
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00859619004875
• UDI-Public: (01)00859619004875(17)191101(01)00818225020648(17)200201(21)207611-70
• 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: 11/30/2018

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: 11/01/2019
• Device Model Number: FR8A-RCV-A0,FR8A-SPR-B0
• Device Catalogue Number: S8R-1A US
• Device Lot Number: SWO171109,SWO180215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/26/2018
• Device Age: 1 YR
• Event Location: Home
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 11/30/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2017
• 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): Other; Required Intervention