MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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Model Number 9735669 |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 02/02/2023 |
Event Type
Injury
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Manufacturer Narrative
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Other relevant device(s) are: product id: 9735736, software version: 1.0.3.A medtronic representative went to the site to test the equipment.Testing revealed that no failures were found.The navigation system then passed the system checkout and was found to be fully functional.Fdm b01, fdr c19, fdc d14 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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Event Description
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Medtronic received information regarding a navigation system being used during a functional endoscopic sinus surgery (fess.) it was reported that during a case, the flat bed emitter had a localizer faulted error.There was a reported delay to the procedure of more than 1 hour due to this issue before the surgeon opted to abort imaging, navigation, and the procedure entirely.The manufacturer representative reached out to the site for patient impact but was unable to obtain the information from the site. .
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Manufacturer Narrative
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H2, h3, h6: software analysis was performed.It was determined that there was insufficient information to determine whether a software anomaly c ontributed to the event.Code d15, and previously reported codes b01 and c19 are applicable.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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