MEDTRONIC NAVIGATION, INC STEALTHSTATION FLEXENT; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
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Model Number 9736242 |
Device Problems
Imprecision (1307); Human-Device Interface Problem (2949); Data Problem (3196)
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Patient Problems
Headache (1880); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/07/2022 |
Event Type
Injury
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Manufacturer Narrative
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Patient information was unavailable from the site.Other relevant device(s) are: product id: 9736226, version: 1.3.2.No parts have been received by the manufacturer for evaluation.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 in a procedure.It was reported that the site was having issues with registration.During accuracy verification the error was sometimes 1cm.It was reported that 2 patients had already cerebrospinal fluid leaks. the site gathered too many points during the registration and instead of reset tracer, they chose to gather more points.It was also reported that "the health care professional draws in the forehead but the line comes down on the nose".It suggests that either the patient orientation was not set up properly or that the patient tracker was upside-down.The last issue that was found was that the site was using scans that were not made according to protocol.They were too thick (3mm) and this might have also influence accuracy.Both imaging and navigation were aborted causing less than an hour delay in the case.
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Event Description
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Additional information received from a manufacturer representative indicated the site did not want to share an explanation regarding the cases.The surgeons were not entirely sure the issues experienced were related to the navigation system.
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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.
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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.Codes b01, c19, and previously reported code d15 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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