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

Model Number FR8A-SPR-B0

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

Patient Problem Unspecified Infection (1930)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

Immediately following notification, stimwave quality and the clinical specialist 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-spr-b0) was implanted at the t8-t9 vertebral level.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 procedure was completed without complication, and the clinical specialist maintained contact with the patient following implant.The patient visited the implanting clinician and their territory manager for their first follow up post-implant procedure.The territory manager reported to their clinical specialist that the patient was doing well following the procedure.The patient was receiving therapy from their implanted device and the implant wounds were healing appropriately.The clinical specialist met with the patient on (b)(6) 2019 and reported the patient's bandages were removed and the implant site looked well.On (b)(6) 2019, the clinical specialist was notified by the implanting clinician that the patient was reporting drainage and the needle entry site was irritated.No cultures were taken of the wound site; however, the implanting clinician made the decision to explant the device the same day prophylactically.The patient reported getting therapy from their device up until the moment of explant.It is likely the wound was not completely healed at the moment the bandages were removed which could have led to the unconfirmed 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 nerve stimulators that is mitigated as far as possible in the product's risk management file.The source of the issue cannot be traced back to the device 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 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 likely due to contamination of the wound site after bandaging was removed.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 adverse event, mitigated as far as possible, and documented in the stimwave risk management file.Stimwave was in constant contact with the clinical specialist from (b)(4) 2019, onward regarding the complaint and the root cause investigation.Stimwave confirmed that the product did not fail to meet performance and safety specifications.The source of the issue is attributed to contamination of the wound site.Stimwave has informed all parties that the product was not the source 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 the event resulted in an injury that required medical or surgical intervention to prevent or preclude permanent impairment or damage.This event was reported to the united states food and drug administration (fda) on december 11, 2019.

Event Description

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

• Brand Name: FREEDOM SPINAL CORD STIMULATOR
• 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: 9454363
• MDR Text Key: 186812498
• Report Number: 3010676138-2019-00062
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020648
• UDI-Public: (01)00818225020648(17)210601
• 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: 12/11/2019

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: 01/06/2021
• Device Model Number: FR8A-SPR-B0
• Device Lot Number: SWO190614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/06/2018
• 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