Model Number BI70002000 |
Device Problems
Communication or Transmission Problem (2896); Unexpected/Unintended Radiation Output (4028)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/22/2023 |
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.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 an imaging system during a sacroiliac and thoracolumbar procedure.It was reported that in the middle of inserting an implant, the navigation system froze.Both screens would not respond, the medtronic representative (rep) tried shutting the system down and rebooting it.The system worked long enough for the rep to attempt to retransfer the imaging system ct images that had been taken at the beginning of the case but the screen froze once more.Because of this, the site had to bring in a new stealth system and were unsuccessful in transferring the patients' imaging system images.The site then had to do another navigated imaging system spin, resulting in unnecessary radiation and more time on the table for the patient.The surgeons were forced to do two out of four implants without navigation.This has happened multiple times and this was the second time it had happened in the same room with the same case and the same doctor.The use of medtronic imaging and navigation were aborted.There was no imp act on patient outcome.The delay in the surgical procedure was approximately 15 minutes.The imaging system images were transferring normally now.
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Manufacturer Narrative
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Additional info: b5 updated.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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Additional information was received, it was reported that the number of people in the room were 7 excluding the patient.
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Search Alerts/Recalls
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