Model Number BI70002000 |
Device Problem
Failure to Transmit Record (1521)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/25/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H3, h6: no hardware parts have been returned for analysis.B17, c20, d15 are applicable.H6: multiple annex f codes were reported.F26 corresponds to no patient impact.F1908 corresponds to surgical delay of less than 1 hour.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Medtronic received information regarding an imaging system being used during a sacroiliac and thoracolumbar procedure.It was reported that the images were not transferring from the imaging system to the navigation system.The site was also not able to manually push exams.The site confirmed that the correct navigation system was selected, and displayed 3 green boxes.The site confirmed the navigated check box on the pendant was checked to be unknown. the scan did have a nav tag.The site respun but it was unresolved. the site aborted navigation and proceeded using a c-arm.This occurred intraoperatively, and there was a surgical delay of less than one hour.There was no reported impact to patient outcome.
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Manufacturer Narrative
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H3) the manufacturer representative went to the site to test the imaging system.They were unable to recreate the occurrence that was called in.They performed 5 navigated spins.Powered the system and navigation down after each spin and was able to successfully turn on all systems and transfer images and navigate.Performed system checkout.All systems performing to operating standards.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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