Reason/Issue |
Customers reported experiencing false negative responses (the condition where the probe is on a nerve, but no EMG tone is triggered) while using the NIM Vital Nerve Monitoring System. If this problem presents during procedure, potential risks may include delay or cancellation of procedure, nerve damage, facial nerve damage, nerve paresis, and nerve paralysis. Between April 1, 2020, and May 31, 2024, Medtronic has received 70 reports related to this problem, including 10 serious harm reports, one resulting in a cancelled case, the others reporting nerve damage, facial nerve damage, nerve paresis, or nerve paralysis. |