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

Model Number FR8A-RCV-A0, FR8A-RCV-A0, SHRK-ALL-1K

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

Patient Problems Cellulitis (1768); Edema (1820); Fever (1858); Pain (1994)

Event Date 07/25/2019

Event Type  Injury  

Manufacturer Narrative

Stimwave quality has investigated the details regarding a complaint resulting from an infection, skin irritation, and tissue damage reported to stimwave on (b)(6) 2019.Immediately following notification, stimwave quality and the territory manager reviewed events preceding the issue.The patient had a permanent procedure performed on (b)(6) 2019, in which one (1) freedom-8a receiver stimulator (fr8a-rcv-a0), one (1) spare lead (fr8a-spr-b0), and one (1) sandshark injectable anchor (shrk-all-1k) were implanted at the l1 and t12 vertebral level to treat chronic back pain.The agent confirmed that the patient's implant procedure was performed in a sterile environment, sterile field handling protocols were used, the procedure was completed in accordance with the product's instructions for use, and sterile barriers of all products used were intact prior to implant.The procedure was completed without complication, and the field agent maintained contact with the patient following implant.On (b)(6) 2019, the patient visited the implanting clinician's office for a follow up appointment.At this appointment, the clinician identified a possible infection at the implant site.As a precaution, the implanting clinician prescribed keflex (duration and dose unknown).On (b)(6) 2019, the patient contacted the agent to notify him of the visit and that the incision site was improving with antibiotics treatment.The patient reported receiving good pain relief from the device and had no other complications.At no time did the patient, agent, or implanting clinician identify an alleged deficiency in the product with respect to identity, quality, durability, reliability, safety, effectiveness, or performance.On (b)(6) 2019, the patient informed the implanting clinician of experiencing low-grade fever, edema, and pain.Per the implanting clinician's recommendation, the patient reported to the emergency room and was admitted the same day.A surgeon evaluated the wound and determined that the patient had cellulitis at the implant site.The agent reported that the patient tested (b)(6) for (b)(6).The patient was treated with intravenous (iv) antibiotics, and the er surgeon explanted the devices prophylactically on the same date.The explant procedure was performed without reported complication.As of (b)(6) 2019, the patient is doing well and no infection is present.Prior to explant, the patient was experiencing adequate pain relief and has expressed interest in having new devices implanted again following healing.Further evaluation of the patient's medical history found that the patient was receiving decompressive therapy prior to and throughout the implant period, compromising the patient's ability to heal and potentially contributing to the suspected infection.Through a review of sterilization and packaging records for the respective product lots, stimwave has confirmed that the product was delivered sterile, no trend of infection is evident for either lot, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.Infection is a known adverse event for spinal cord stimulators (receiver instructions for use, 05-00629-6, page 14) and is mitigated as far as possible in the product's risk management file.The source of the issue cannot be traced back to device sterility or 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 implant procedure, device failure, the inability of the device to meet performance or safety specifications, or nonconformance to physical or functional device specifications.The root cause of the issue is attributed to patient comorbidities that inhibited wound healing.Corrective action is not required to remedy the root cause of the complaint.The device did not fail to meet performance or safety specifications.Infection is a known adverse event for spinal cord stimulators and the freedom scs system that is mitigated as far as possible and documented in the stimwave risk management file.Stimwave's global infection rate is (b)(4).Stimwave was in constant contact with the field agent from august 14, 2019, onward regarding the complaint and the root cause investigation.Through a review of sterilization records and adverse event trending for the stimulator lots, stimwave confirmed that the product did not fail to meet performance or safety specifications.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 this event required medical intervention by a health care professional to prevent or preclude potential permanent impairment or damage.Stimwave reported this issue to the united states food and drug administration (fda) on august 30, 2019.

Event Description

Stimwave quality has investigated the details regarding a complaint resulting from an infection, skin irritation, and tissue damage reported to stimwave on (b)(6) 2019.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR 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: 8950958
• MDR Text Key: 157739299
• Report Number: 3010676138-2019-00028
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: (01)00818225020693(17)210201(01)00818225020648(17)210201(21)209855-3;(01)00859619004202(17)200301(10)171K9267
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182720
• 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: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2020
• Device Model Number: FR8A-RCV-A0, FR8A-RCV-A0, SHRK-ALL-1K
• Device Lot Number: SWO190227;SWO190227; 171K9267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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