Event date is approximated.Date provided is when the journal article was published.Citation: markowitz, daniel; lin, dishen; salas, sussan; kohn, nina; schulder, michael.¿compact intraoperative mri: stereotactic accuracy and future directions.¿ stereotactic and functional neurosurgery, 95, 2017: 197-204.The exact system information could not be determined as it was not provided.However, the system listed on this form was at the address listed in the article during the time some of the surgeries were completed.Device udi not provided as actual product used for this study is unknown.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No further information provided in the journal article or from the authors.The author could not provide any additional information or insight as he was not at the site when the surgeries were performed.No request for service have been received from the customer regarding these events.No parts have been replaced or returned to the manufacturer for evaluation.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's imaging guidance system and surgical navigation system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.(b)(4).Not returned by customer.
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The attached journal article was forwarded by medtronic representative.Article indicated the use of surgical imaging and navigation system.This is medical device report (mdr) two of two.See 1723170-2018-03437 for the other case.Intraoperative imaging must supply data that can be used for accurate stereotactic navigation.This information should be at least as accurate as that acquired from diagnostic imagers.The aim of this study was to compare the stereotactic accuracy of an updated compact intraoperative mri (imri) device based on a 0.15-t magnet to standard surgical navigation on a 1.5-t diagnostic scan mri and to navigation with an earlier model of the same system.Methods: the accuracy of each system was assessed using a water-filled phantom model of the brain.Data collected with the new system were compared to those obtained in a previous study assessing the older system.The accuracy of the new imri was measured against standard surgical navigation on a 1.5-t mri using t1-weighted (w) images.The mean error with the imri using t1w images was lower than that based on images from the 1.5-t scan (1.24 vs.2.43 mm).T2w images from the newer imri yielded a lower navigation error than those acquired with the prior model (1.28 vs.3.15 mm).Improvements in magnet design can yield progressive increases in accuracy, validating the concept of compact, low-field imri.Avoiding the need for registration between image and surgical space increases navigation accuracy.
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