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

Model Number FR8A-RCV-A0

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 01/25/2019

Event Type  Injury  

Manufacturer Narrative

Stimwave quality has investigated the details surrounding a complaint resulting from device explant and infection reported to stimwave on (b)(6) 2019, by stimwave clinical specialist (b)(4).On (b)(6) 2019, the clinical specialist was made aware of a patient's unconfirmed surgical site infection while attended an appointment with the patient and the implanting clinician for device explant.During this appointment, the patient reported that she had returned to the implanting clinician's office for treatment on (b)(6) 2019 for pain and drainage at the implant site.The implanting clinician recounted that he prescribed antibiotics (clindamycin 300mg and keflex) at this appointment, but the patient did not present with a fever, or a history of fever since the implant procedure.The implanting clinician informed the clinical specialist that he told the patient that if no improvement was observed within four (4) days following the initial visit on (b)(6) 2019, that explant might be necessary.The patient returned as requested to the implanting clinician's office on (b)(6) 2019 and the patient reported no fever, no drainage, but some pain at the surgical site.Thus, the patient elected to have the devices explanted.The clinical specialist was not aware of the patient's visits to the implanting clinician and the patient until the appointment on (b)(6) 2019 for device explant.Immediately following notification, stimwave quality and management contacted the clinical specialist to discuss the events leading up to awareness of the issue and review the implanting clinician's procedure compared to instructions for use.The clinical specialist 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 patient was implanted with the freedom spinal cord stimulator (scs) system on (b)(6) 2018, in which one (1) freedom-8a receiver stimulator (fr8a-rcv-a0) was implanted in the patient's epidural space at t10 to treat the patient's post-laminectomy syndrome resulting in low back pain that radiates into bilateral hip pain, with more pain in the right side as compared to the left.The implanting clinician noted that he was only able to advance the stimulator to mid t10 level in the patient's epidural space due to scar tissue.The clinical specialist reported to stimwave that while the implanting clinician observed that the patient's wound site was not healing, he did not observe any signs of infection, and prescribed antibiotics as precaution.The implanting clinician did not collect a culture of the wound site.Additionally, the implanting clinician informed the clinical specialist that he suspected the cause of the pain and drainage was likely attributed to his surgical technique for securing the stimulator and fixating the receiver.He reported that upon retrospective review of the instructions for use, the stimulator was not secured deep enough and the receiver was placed too shallow.The procedure for anchoring the stimulator (electrode array ifu) instructs clinicians to employ the use of the sandshark injectable anchor (sia) system to secure the device beneath the fascia and anterior to the ligamentum flavum (05-00762-1, page 21, k180981).The clinical specialist informed stimwave that this step was not followed, as the sia system was not available at the time of the procedure.The procedure for coil and fixate the receiver (receiver ifu) instructs clinicians to tie a knot using the remaining receiver tubing, and coil the remaining tubing into a 3cm diameter coil and tie a square knot around the coil and into the fascia at three locations and at the marker band (05-00629-5, page 19, k180981).While these steps are intended for migration mitigation, the physiological landmarks (ligamentum flavum and fascia) are described in the ifus to note the depth requirement.It is unknown if the clinician prescribed antibiotics following the implant procedure.Patient compliance with infection prevention protocols is also unknown.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.Stimwave review the lot history distribution, and no trends of infections were noted.Surgical site infection is a known complication of surgery.While the infection was not confirmed, the implanting clinician recognized that noncompliance to implantation procedures contributed to the issue.It is also possible that the patient's past surgical procedures and scarring prevented the implanting clinician from placing the stimulator at the appropriate level to best cover that patient's pain.The source of the issue is likely attributed to clinician noncompliance to documented instructions for use, patient physiology resultant of surgical procedures preceding the implantation of the freedom scs system, potential patient noncompliance to infection prevention following a surgical procedure.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 physician noncompliance to implantation procedure, patient physiology, patient compulsion, and/or suturing procedure during implantation.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 february 1, 2019, 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) on february 12, 2019.

Event Description

On (b)(6) 2019, the clinical specialist was made aware of a patient's unconfirmed surgical site infection while attended an appointment with the patient and the implanting clinician for device explant.During this appointment, the patient reported that she had returned to the implanting clinician's office for treatment on (b)(6) 2019 for pain and drainage at the implant site.The implanting clinician recounted that he prescribed antibiotics (clindamycin 300mg and keflex) at this appointment, but the patient did not present with a fever, or a history of fever since the implant procedure.The implanting clinician informed the clinical specialist that he told the patient that if no improvement was observed within four (4) days following the initial visit on (b)(6) 2019, that explant might be necessary.The patient returned as requested to the implanting clinician's office on (b)(6) 2019 and the patient reported no fever, no drainage, but some pain at the surgical site.Thus, the patient elected to have the devices explanted.The clinical specialist was not aware of the patient's visits to the implanting clinician and the patient until the appointment on (b)(6) 2019 for device explant.

• 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: 8333914
• MDR Text Key: 136004948
• Report Number: 3010676138-2019-00006
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 008596199004875
• UDI-Public: (01)008596199004875(17)191001
• 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: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2019
• Device Model Number: FR8A-RCV-A0
• Device Lot Number: SWO171024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/01/2019
• Device Age: 16 MO
• Event Location: Outpatient Treatment Facility
• Date Manufacturer Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• 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): Required Intervention