Dive Brief:
- Medtronic has recalled a nerve monitoring system linked to 10 injuries, the Food and Drug Administration said Tuesday.
- The devices are staying on the market but Medtronic warned that no tone may trigger when the device is on a nerve, which could lead to injuries including nerve damage.
- Medtronic is deploying a software update to fix the issue and advising surgeons to rely on alternate methods, surgical skills, experience and anatomical knowledge to prevent damage to nerves if monitoring is compromised.
Dive Insight:
Healthcare professionals use Medtronic’s NIM system to locate, monitor and stimulate nerves during surgery. When placed on a nerve, the system issues an electromyography tone to help prevent damage.
Medtronic sent an urgent notice in June in response to reports of false negatives from customers. The users found their systems failed to issue a tone when placed on a nerve. Medtronic received 70 reports about the issue from April 2020 to the end of May.
The notices included 10 serious harm reports. One report described the cancellation of a case. The other reports covered instances of nerve damage, facial nerve damage, nerve weakening or nerve paralysis linked to the issue. The FDA categorized the problem as a Class I recall because of the risk of serious injury.
Medtronic’s investigation found a “noise and artifact due to system fault could interact with the auto threshold and wireless muting functions, if enabled, resulting in the potential for a false negative response.” The company addressed other potential causes of false negatives. Medtronic also made changes to “correct the potential for failure of stimulator calibration, fuse check and data processing functions.”
Version 1.5.4 of the NIM software features fixes for the false negative problem. Medtronic told users it will contact them to install the new software version. Until the software is installed, the FDA is advising users to “follow organizational medical protocols in place for patients who are currently being monitored.”