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What's the Problem?
The FDA on April 27, 2022, issued a Warning Letter to Health Care Providers [1] stating that the agency is evaluating the potential airway obstruction risks when using silicone-based electromyogram (EMG) endotracheal tubes (Medtronic NIM Standard Reinforced EMG Endotracheal Tube and Medtronic NIM Contact Reinforced EMG Endotracheal Tube) for esophagael intubation.
"The FDA has received reports describing serious adverse events and deaths for these devices after patient's airway obstruction incidents and ventilation failure," FDA said. "If the tube does not ventilate properly during esophageal intubation, patients may suffer oxygen deprivation, brain damage, or death."
FDA is currently unable to determine the root cause and incidence rate of obstruction and ventilation failure with the use of Medtronic Endotracheal Tubes. However, information from medical device reports (MDRs) currently suggests that reported events of airway obstruction are more frequent for silicone-based EMG tubes compared to other tubes.
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Risks of Silicone Endotracheal Tubes
- Airway Obstruction
- Ventilation Failure
- Oxygen Deprivation
- Brain Damage
- Death
What are Endotracheal Tubes Used For?
EMG endotracheal tubes have electrodes for monitoring the integrity of nerves to the laryngeal musculature. These tubes are intended to provide an airway for patient ventilation and allow for intraoperative monitoring of EMG activity of the laryngeal musculature during surgery when connected to an appropriate EMG monitor.
These devices are 510(k) cleared and are made from either polyvinyl chloride (PVC) or silicone elastomer. In the U.S., the currently marketed silicone-based EMG tubes are the Medtronic NIM Standard Reinforced EMG Endotracheal Tubes and Medtronic NIM Contact Reinforced EMG Endotracheal Tubes.
FDA Recommendation
FDA is encouraging patients to report adverse events related to silicone-based EMG endotracheal tubes to the manufacturer and the FDA. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
Get a Free Lawsuit Evaluation With Our Lawyers
The Medical Malpractice Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Medtronic Endotracheal Tube Lawsuits. We are handling individual litigation nationwide and currently accepting new medical malpractice cases in all 50 states.
If you or a loved one was injured by a Medtronic Endotracheal Tube, you should contact our law firm immediately. You may be entitled to a settlement by filing a lawsuit, and our lawyers can help you receive fair compensation.
