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Model Number 9735602 |
Device Problem
Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical product: other relevant device(s) are: product id: 9 660651.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 from a manufacturer representative (rep) regarding a navigation device being used outside of a procedure.It was reported that there were red status em details.Em interface revealed fault codes listed for power status, all four.There was no patient harm or additional complications reported or anticipated as a result of the event.
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Manufacturer Narrative
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D10: the lot number of the axiem is 0200057747.H3, h6: the portable axiem was returned for product analysis.The axiem was tested and upon initial power up communication was established and the unit tracked tools as expected.The unit was then power cycled and did not establish communication, and the led display on the back did not display any number.After multiple power cycles, the power up and establishment of communication was intermittent and the system would not communicate more than 50% of the time.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.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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H3, h6: a medtronic representative went to the site to perform a system checkout.The axiem was replaced and the system passed checkout.Fdm b01, fdr c02, fdc d02 are applicable to the system checkout.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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