MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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Model Number 9735665 |
Device Problems
Communication or Transmission Problem (2896); Computer Operating System Problem (2898); Human-Device Interface Problem (2949)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/10/2022 |
Event Type
malfunction
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Event Description
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Medtronic received information regarding a navigation system used outside a procedure.It was reported there was a problem with the touch, slow registration process, and pop up windows that appear without clicking anything.No patient present.
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Manufacturer Narrative
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Concomitant medical products: other relevant device(s) are: product id: 9736403, serial/lot #: (b)(4).Product id: 9736356, serial/lot #: (b)(4).Product id: 9735818, serial/lot #: (b)(4).A medtronic representative went to the site to test the equipment.Testing revealed that the computer, solid state drive (ssd), and i/o (input/output) panel assembly were replaced.The navigation system then passed the system checkout and was found to be fully functional.The computer was returned to the manufacturer for analysis.The computer was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.The i/o panel assembly was returned to the manufacturer for analysis.The i/o panel assembly was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.The ssd was returned to the manufacturer for analysis.Analysis found that the ssd booted up to the "advanced options for ubuntu" screen, and then would go to a black screen with a blinking cursor after three seconds.There was no os found on the ssd, and logs were unable to be pulled.Analysis found that the reported event was related to a software issue.(b)(4).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.
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Manufacturer Narrative
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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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Event Description
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2022-nov-17 e2 (rep, for): no new information.
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Search Alerts/Recalls
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