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

Model Number FR8A-RCV-A0;FR8A-SPR-B0;SHRK-ALL-1K

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

Patient Problem Bacterial Infection (1735)

Event Date 09/04/2019

Event Type  Injury  

Manufacturer Narrative

Stimwave quality has investigated the details regarding a complaint resulting from a potential infection reported to stimwave on september 4, 2019, by stimwave agent.The agent was made aware of the issue at a follow-up appointment on the same day.Immediately following notification, stimwave quality and the agent reviewed the 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) freedom-8aspare lead (fr8a-spr-b0), and one (1) sandshark injectable anchor (shrk-all-1k) were implanted at the t8-t9 vertebrae to treat the patient's chronic back pain.The agent 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 procedure was completed without complication, and the agent maintained contact with the patient following implant.On (b)(6) 2019, at a follow up appointment, the patient reported a potential infection at the wound site.The implanting clinician and the agent noted that the wound site was healing, but some drainage was present.The implanting clinician elected to prophylactically explant the devices on this date.Cultures were taken, and the patient was prescribed antibiotics (type, dose, and duration unknown).The agent confirmed that all devices were explanted without complication and that the patient was receiving therapy until the moment of explant.The implanting clinician and agent believe that the infection was attributed to non-compliance to wound care instructions and the device was not the cause of the issue.On (b)(6) 2019, the patient visited the implanting clinician's office for a follow-up appointment.During this visit, the agent was notified that the results for the cultures were positive for gram-positive cocci methicillin-sensitive staph.The patient continued antibiotic treatment at home.Infection is a known adverse event for the freedom scs system (receiver instructions for use, 05-00629-6, page 14), and is detailed in stimwave's risk management file as well as applicable instructions for use and patient-facing labeling.Stimwave's global infection rate is <0.5%.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.The root cause of the complaint is not attributed to device failure, the inability of the device to meet performance or safety specifications, or nonconformance to physical or functional device specifications.The stimwave product was not the source of the issue.The root cause of the issue is attributed to patient non-compliance to post-operative wound care instructions.Corrective action is not required to remedy the root cause of the complaint, as the device did not fail to meet performance or safety specifications.Stimwave has confirmed that the issue is a known adverse event, mitigated as far as possible, and documented in the stimwave risk management file.Stimwave was in constant contact with the agent from september 4, 2019, onward regarding the complaint and the root cause investigation.Stimwave confirmed that the implant procedure details steps to mitigate migration and 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 october 2, 2019.

Event Description

Stimwave quality has investigated the details regarding a complaint resulting from a potential infection reported to stimwave on september 4, 2019, by stimwave agent.The agent was made aware of the issue at a follow-up appointment on the same day.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR (SCS)
• 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: 9145655
• MDR Text Key: 167410125
• Report Number: 3010676138-2019-00030
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: (01)00818225020693(17)210201(01)00818225020648(17)210601(21)201275-19;(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: 10/02/2019

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: 02/01/2021
• Device Model Number: FR8A-RCV-A0;FR8A-SPR-B0;SHRK-ALL-1K
• Device Lot Number: SWO190227;SWO190614;171K9267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 10/02/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2019
• 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