Medtronic’s NIM System Issue Assigned as a Class I Recall

Throughout surgery, medical personnel find, track, and trigger nerves using Medtronic’s NIM system. To assist stop harm, the device produces an electromyography tone when it comes into contact with the neurones.

In June, Medtronic issued an immediate alert in light of consumer complaints about erroneous adverse outcomes. Once individuals touched a nerve, their systems did not produce a tone. Medtronic was notified of the problem in 70 instances between April 2020 and the conclusion of May.

Among the alerts were ten reports of significant damage. A case that was cancelled was mentioned in one report. The other papers discussed related cases of nerve injury, including harm to the face, nerve weakness, and nerve immobility. Because there is a chance for severe harm to occur, the FDA classified the issue as a Class I recall.

The NIM software has been updated to version 1.5.4, which addresses the issue of fake negatives. Customers are to be contacted by Medtronic to set up the newly released software. The FDA is encouraging customers to “follow organisational medical protocols in place for patients who are currently being monitored” while the program is being deployed.