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Model Number 9733858 |
Device Problems
Device Sensing Problem (2917); Failure to Shut Off (2939)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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No patient information provided as no patient was involved in this concern.A medtronic representative went to the site to test the equipment.Testing revealed that the reported issue could not be replicated.The system then passed the system checkout and was found to be fully functional.Concomitant medical products:: product id: 9 733686, serial/lot #: 2.0.1, ubd: , udi#: 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 device being used outside of a procedure.It was reported that spine instruments were not visible.It was reported that after starting the spine application software, no spine instruments were visible.When attempting to restart the navigation system, the computer would not shut down.There was no patient present when this issue was identified.Additional information was received.It was reported that the small passive spine reference frame was not visible to the navigation system.Troubleshooting on-site found that the reference frame was inadvertently removed from the working instruments list but was available in admin settings.It was reported that the allegations of the computer not shutting down did not occur and that the issue was isolated to the reference frame.
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Manufacturer Narrative
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H3: a software analysis was initiated as part of the investigation.Analysis found that the system software functioned as designed.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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