The FDA is alerting healthcare providers to a medical device recall from Medtronic for its nerve monitoring system that has been linked to 10 injuries.
The agency handed down a Class I recall label to the issue, its most serious risk designation.
The devices are staying on the market as the recall involves correcting the devices and does not involve removing them from where they are used or sold, the FDA said.
Medtronic said it is correcting its NIM Vital Nerve Monitoring System product after reports of false negative responses. This can occur during procedures, where the device may fail to issue an electromyography (EMG) tone when the NIM probe is placed on a nerve.
"The use of affected product may cause serious adverse health consequences, including nerve damage, facial nerve damage, nerve weakening (paresis), and nerve paralysis," according to the FDA's notice.
There have been 10 reported injuries and no reports of death.
Between April 1, 2020, and May 31, 2024, Medtronic received 70 reports for this potential issue including 10 serious harm reports, one resulting in a canceled case, the others reporting nerve damage, facial nerve damage, nerve paresis or nerve paralysis, according to a field safety notice the company issued in June.
Medtronic's nerve monitoring system is used during surgery to locate, monitor and stimulate the nerves of the skull and spine as well as the nerves that connect the brain and spinal cord to muscles and/or sensory cells. The system issues an EMG tone when the probe is placed on a nerve to help prevent nerve damage during surgery.
Medtronic's urgent medical device correction notice issued two months ago targeted products with model numbers NIM4CM01, NIM4CPB1 and NIM4SWU143, due to the potential for a false negative response. The field safety corrective action was initiated because customers reported experiencing false negative responses, or the condition where the probe is on a nerve, but no EMG tone is triggered, while using the nerve monitoring system, Medtronic wrote.
Medtronic said it is deploying a software update, software version 1.5.4, to fix the false negative problem. Changes were also made to correct the potential for failure of stimulator calibration, fuse check and data processing functions, the company wrote. Medtronic said it will contact each organization to install the software update.
Until the software is installed, the company is advising users to follow organizational medical protocols in place for patients who are currently being monitored. The company also is advising surgeons to rely on alternate methods, surgical skills, experience and anatomical knowledge to prevent damage to nerves if monitoring is compromised.