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Model Number 2021001 |
Device Problem
Failure to Deliver Shock/Stimulation (1133)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/08/2022 |
Event Type
malfunction
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Event Description
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While attempting to start stimulation using an nvm5 device for neuromonitoring during an extreme lateral interbody fusion (xlif) procedure, the nvm5 experienced an error which stopped stimulation functionality.Several troubleshooting attempts were made; however, the issue could not be resolved.As a result, neuromonitoring could not be performed and the surgeon had to change the surgical plan, closing the xlif surgical site and performing a transforaminal lumbar interbody fusion procedure instead.There was no further patient impact reported.
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Manufacturer Narrative
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The unit was returned for evaluation.The unit was found to exhibit a windows error that impacted function and required reimaging to resolve.No other issues were found during inspection and testing.The unit was reimaged and passed all final inspection and testing criteria.Labeling review: ".As with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries." ".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." ".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.".
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Search Alerts/Recalls
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