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Important Message to Members: Notification of NIM Vital Nerve Monitoring System Concerns

Important Message to Members: Notification of NIM Vital Nerve Monitoring System Concerns

The NIM Nerve Monitoring System, manufactured by Medtronic, has become an invaluable tool for surgeons operating around cranial and peripheral nerves to monitor and help preserve their function during both routine and complex surgical procedures. Since Medtronic has introduced the NIM VitalTM as the successor product to the NIMTM 3.0, surgeons transitioning to the NIM Vital have reported concerns about the function of the system in several areas that could compromise intraoperative patient safety. These areas include the alarm process, false positive and negative responses, and the stimulation function.

The leadership of the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS),  American Neurotology Society (ANS), and American Otological Society (AOS) have been working collaboratively with Medtronic and the U.S. Food and Drug Administration (FDA) to describe the areas of concern and work toward solutions that will address the areas of concern and thereby maximize the value of this critical tool to the surgical community, which relies on the product to improve patient safety.

The AAO-HNS, ANS, and AOS are committed to work with Medtronic and the FDA to be a part of a solution that will benefit all. We need your help. It is important to have an accurate picture of what is happening broadly across the specialty. If you have experienced any issues with the NIM Vital Nerve Monitoring System, please report it to Medtronic as well as directly to the FDA via this site:

https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda

Thank you in advance for your help.

Sincerely,

Douglas D. Backous, MD
AAO-HNS President

Elizabeth H. Toh, MD
ANS President

Sujana S. Chandrasekhar, MD
AOS President

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