Model Number BI70002000 |
Device Problems
Poor Quality Image (1408); Connection Problem (2900); Output Problem (3005); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/15/2022 |
Event Type
malfunction
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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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Event Description
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Medtronic received information regarding an imaging system being used during a spinal procedure.Following a procedure, when the surgeon wanted to verify placement of the implantable, the scanned thumbnail image of the image acquisition showed as black on the mobile viewing station (mvs).When double-clicking on the exam, pictures of the scan would load.However, when pushing the images to picture archiving and communication systems (pacs), a digital imaging and communications in medicine (dicom) error would be received.It was noted the "nav" tag was present.Several other attempts were made to push the exam without resolution.The site also tried to take a 2d image acquisition.When attempting to push to pacs, the image thumbnail was black and the dicom error was also present.The dose report also failed and was completely black.For further troubleshooting, the navigation system was not present to push exams.Another cable and network port were attempted.The reported issue did not result in a procedure delay.There was no impact on patient outcome.
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Search Alerts/Recalls
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