Important Safety Alerts

Medtronic has issued a medical device safety alert concerning its NIM Trivantage EMG Endotracheal Tube [Product Name: EMG TUBE 8229737 3PK NIM TRIVANTAGE 7MM & EMG TUBE 8229738 3PK NIM TRIVANTAGE 8MM Model number: 8229737 & 8229738, Material#: 20763000041520 & 20763000041537].

The manufacturer has received complaint reports from customers experiencing issues with the Trivantage EMG Tubes during use. Reported issues include users:

• Experiencing difficulty passing the Electrode Check on the NIM Mainframe immediately after intubating the patient
• Losing the connection between the EMG Tube and the Mainframe during a procedure, resulting in an "Electrode Off," "Lead Off," or "Channel Not Reading" error message on the NIM console screen and the inability to proceed with nerve monitoring
• Receiving excess signal noise from the NIM console due to lead-off issues

If any of these issues are identified during surgery, the risks associated with a non-conforming Trivantage EMG Tube could potentially result in:

• A case being canceled after the patient is anesthetized
• Possible nerve damage

From 1-Nov-2019 to 31-Oct-2021, the manufacturer received 163 complaints worldwide. Of these complaints, there were four (4) cases of aborted procedures and one (1) case of nerve damage. The remaining complaints did not result in serious patient injury.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 20 Dec 2021