During routine servicing of the nvm5 unit, it was found the unit failed simulated stimulation testing; specifically, an unresolvable windows error message occurred during dynamic emg stimulation, which stopped stimulation functionality.The unit required reimaging to resolve the error.There was no patient involvement.
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The device was received and evaluated.The evaluation found the unit failed simulated stimulation testing; specifically, an unresolvable windows error message.The cause of the stimulation failure was a windows issue and was resolved by reimaging the unit.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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