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Model Number 9735602 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: other relevant device(s) are: product id: 9660651, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information regarding a navigation device that was used outside of procedure.It was reported that the axiem was newly received and open from new box.Axiem was found faulty and cannot connect to the monitor.Navigation led was not lit and no error appear at led at the back.No patient present.No system serial number, account name, or account number was provided in the mpxr.
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Manufacturer Narrative
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D1, d2, d4 correction) corrected device information provided.E1, e4 correction) correct initial reporter contact information and correct country provided.G3 correction) initial report sources included distributor.H3 device evaluation) a medtronic representative indicated the electromagnetic localization box was replaced with another one and the system functioned normally.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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Manufacturer Narrative
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H6: the axiem box was returned to the manufacturer for analysis.Axiem was tested and upon initial power up communication was established and the unit tracked tools as expected.Unit was then power cycled and would not establish communication, the led display on the back would not display any number.After multiple power cycles the power up and establishment of communication was intermittent and would not communicate more than 50% of the time.The hardware investigation found that the reported event was related to a hardware issue.H6: fdm 10, fdr 120, fdc 4307.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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Search Alerts/Recalls
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