Medtronic NIM Standard Reinforced EMG

2022: US authorities report fatalities using defective Medtronic endotracheal tubes

In early May 2022, the United States Department of Health reported that it began assessing the risk associated with silicone-based Medtronic endotracheal tubes for the electromyogram after reports of fatalities and serious adverse events in patients.

In late April 2022, the Food and Drug Administration (FDA) issued a warning in a letter to health care providers regarding the endotracheal tubes of Medtronic NIM Standard Reinforced EMG and Medtronic NIM Contact Reinforced EMG Endotracheal Tubes. These are the only silicone-based electromyogram (EMG) tubes sold in the United States.

Reported fatalities using defective Medtronic endotracheal tubes

Following the instructions given in the marking of the device, the risk of airway obstruction can be reduced. Physicians should be prepared to urgently eliminate airway obstruction and impaired ventilation if this occurs during surgery by restoring safe airways and re-intubation if necessary with a new tube that is not a silicone-based EMG endotracheal tube, said U.S. Department of Health specialist Sarah Kotler.

The department said there is a risk of airway obstruction, impaired ventilation, oxygen starvation and death due to 510 (k) -clear certified tubes that provide airways during surgery and use electrodes to control nerves to laryngeal muscles when connected to an EMG monitor. The US Department of Health added that the main cause and frequency of cases are unknown, and that it did not receive similar reports of EMG tubes made of polyvinyl chloride (PVC). The agency works with Medtronic to further assess the problem and identify potential contributing factors and strategies to reduce it^[1]

Notes