Medtronic NIM Vital Nerve Monitoring System Recall Issued After Injuries Reported

FDA determined a Medtronic device correction notice constituted a NIM Vital Nerve Monitoring System recall, following at least 10 reports of patient injuries.

Federal regulators indicate that a correction notice issued for the Medtronic NIM Vital Nerve Monitoring System constitutes a Class I medical device recall, since problems with the monitoring system may cause severe injury or death for patients.

The U.S. Food and Drug Administration (FDA) announced the Medtronic NIM Vital Nerve Monitoring System recall designation on August 6, following at least 10 reports of injuries that may have resulted when the devices failed to issue an alert when the probe is placed on a nerve.

The NIM Vital Nerve Monitoring System is used during surgery to locate, monitor, and stimulate the nerves in the skull and spine, which also connect the brain and spinal cord to the muscles and sensory cells.

The device is supposed to issue an electromyography (EMG) tone when the probe is placed on a nerve, to help doctors avoid any surgical nerve damage during proceedures. However, reports suggest that there have been a number of false negative responses associated with the device.

The FDA warns that if the devices fail to issue an EMG tone when the NIM probe is placed on a nerve, it could cause a doctor to incorrectly determine there is no risk to the nerve in the area. As a result, patients may face an increased risk of nerve damage, facial nerve damage, nerve weakening, and nerve paralysis. Although 10 adverse event reports have been linked to the false negative responses, no deaths have been identified to date.

Information about the problems were previously outlined in a correction notice issued by Medtronic in June, which was sent to affected customers.

A correction does not remove the devices from the market. Instead, Medtronic will slate the devices for a fix for the issues via a system update later. However, the FDA designated this a class I recall, the most serious type of recall because the device may cause serious injury or death if patients continue to use it without correction.

The recall includes NIM Vital Nerve Monitoring System models: NIM4CM01, NIM4CM01RF, NIM4CPB1, NIM4CPB1RF, and NIM4SWU143. Medtronic is deploying the NIM Vital System software version 1.5.4 to fix the issue and will contact customers for the fix when it is ready.

The FDA and Medtronic warned that medical facilities must be aware that using the devices may lead to the possibility of a false negative, where stimulation is applied but no EMG output is identified to the user.

Additionally, Medtronic indicates healthcare providers should follow protocols for patients who are currently being monitored with the NIM system to help reduce the risk of nerve injury from false negative readings. They should also use alternative monitoring, surgical skills, experience, and anatomical knowledge to prevent damage to the nerves if monitoring is compromised.

Customers in the U.S. with questions are urged to contact their Medtronic Representative or Medtronic Customer Quality at RS.JaxProductQuality@medtronic.com.