MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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Model Number 9735665 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/12/2021 |
Event Type
malfunction
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Event Description
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Medtronic received information regarding a navigation system and automated trajectory guidance unit being used outside of a procedure.It was reported that the control unit of the guidance unit lost display functionality when moving the unit.It was reported that the buttons could be used to move the targeting unit but the display was blank.It was noted that the system and guidance unit had booted without issue.There was no patient present when this issue was identified.
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Manufacturer Narrative
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No parts have been received by the manufacturer for evaluation.Other relevant device(s) are: product id: 29631, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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The control unit for the automated trajectory guidance unit was returned to the manufacturer for evaluation.Analysis found that the display functionality was lost after ~15 minutes of use.Rebooting the unit resulted in the display not powering on.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.Continuation of d10) pn: 28080, ln/sn: 0059 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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A medtronic representative went to the site to test the equipment.Testing revealed that the control unit of the automated trajectory guidance unit.The navigation system then passed the system checkout and was found to be fully functional.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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