Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9736356.G2) foreign country: japan.H3) a manufacturer representative went to the site to test the navigation system.Hardware parts were replaced and the system performed as intended.Codes: b01, c19, d15.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 outside of a procedure.It was reported that when upgrading the navigation system to a new software application, an attempt was made to upgrade the operating system to 2.0.3, but the wrong operating system was mistakenly installed.The screen display failed then. there was no patient involvement.
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