The device was received and evaluated.The evaluation confirmed the initially reported condition of the unit freezing with a black screen during power up and found the unit failed to stimulate during simulated stimulation testing.The cause of the freezing with a black screen was determined to be a faulty main circuit board and the cause of the failed stimulation testing was resolved by reseating the stimulation circuit board and edge cards.Labeling review: ".While the nvm5 system is designed to assist in the electromyographic location of spinal nerves in proximity to the surgical site, it is not intended to take the place of thorough knowledge of spinal anatomy and appropriate surgical technique, nor should the information provided by the system be construed as definitive indicators of nerve location.Such factors as the distance from the nerve, the position and placement of electrodes, individual muscle and/or nerve responses, the proximity and strength of sources of electrical interference, and other patient and environmental factors, may influence the operation.If, in the judgment of the clinician, this resistance is sufficient to preclude proper placement of instruments, the procedure should be suspended." ".If system data acquisition seems inaccurate or if the software application does not initiate or malfunctions during use, and recommended steps to restore the system are not successful, abort use of the system.".
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The event was re-evaluated 06/03/2022 and it was determined to not be reportable thought the report indicates the malfunction of a nuvasive device.There is no indication of an adverse reaction, death or serious injury, or the need for intervention to prevent death or serious injury.The previously identified failed patient stimulation, indicating the unit has a malfunction that is likely to lead to serious injury was inaccurate as the failed stimulation testing was an autotest that failed due to the failed boot sequence and disallowing a patient simulation or even power up to be completed.It is considered highly unlikely death or serious injury could take place should this or a similar event recur.No reporting is required on this event.Gpanfili 06/03/2022.
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