It was noted that this issue occurred during multiple surgical procedures, but the patient/procedure information for each of the cases could not be obtained.Other relevant device(s) are: product id: 9731203, serial/lot #: unknown.A medtronic representative went to site and performed a system checkout.It was noticed that a loaner emitter improved tracking, so the emitter was replaced.The system then passed checkout.If information is provided in the future, a supplemental report will be issued.
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Concomitant medical products: the lot number was updated: serial/lot #: (b)(6) analysis was done, and originally it was reported that the problem could not be duplicated.The field generator was connected to a test system for a burn-in test.The system remained in green status during all testing.Flexing the cable does not indicate any intermittent opens.Fully functional.However it was then updated to say that the reported problem was confirmed.Instrument would become unstable for a short period of time and would track normally most of the time.Failure would happen intermittently.H6) 10,120,4307 are associated with the product analysis on the instrument.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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