Concomitant medical products: section d information references the main component of the system.Other relevant device(s) are: product id: 9735740, version: 1.3.2, ubd: unknown, udi#: unknown h3, h6: no products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Medtronic received information regarding a navigation system being used during a sacroiliac and thoracolumbar procedure.It was reported that the system displayed error code 64 while re-registering a patient using computed tomography (ct) touchpoint for a scoliosis case.The issue happened when they went back from navigation to registration.Once the previous touchpoints were deleted, the registration model disappeared.A few seconds later, the screen went dark and an error message appeared.The system likely rebooted (either reboot or re-loading the operating system [os]) after the error message, and functioned normally after the self reboot.There was a reported delay to the procedure of less than five minutes due to this issue.There was no reported impact on patient outcome.
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