Medtronic NIM Vital Nerve Monitoring System Correction Deemed Class I

Medtronic’s NIM Vital Nerve Monitoring System recall has been identified as Class I after it was found that the system had the potential for false negative responses. The recall is a correction, not a product removal.

The nerve monitoring system is used to locate, monitor, and stimulate the nerves of the skull during surgery, as well as the nerves that connect the brain and spinal cord to muscles or sensory cells. The system issues an EMG tone when the probe is placed on a nerve to help prevent nerve damage during surgery.

NIM is being corrected due to reports of false negative responses during procedures where the device may fail to issue an electromyography tone when the probe is placed on a nerve. Use of an affected device may result in nerve damage, facial nerve damage, nerve weakness, and nerve paralysis, according to Medtronic. Currently, there have been 10 reported injuries and no deaths associated with the recall.

The company sent an Urgent Medical Device Correction Letter to customers in June noting that the product is not required to be returned as software version 1.5.4 has been deployed to fix the issue.