Model Number BI70002000 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); 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 07/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: serial/lot #: unknown.H3) a manufacturer representative went to the site to test the imaging system.The hand switch was replaced and the system performed as intended.Codes: b01, c07, d02 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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Medtronic received information regarding a navigation device being used during a sacroiliac and thoracolumbar procedure.It was reported that the system was having difficulties taking three dimensional (3d) spins.The field representative (rep) stated the system would sit on the loading page for the scan and they would need to stop and reinitiate the spin since breath was being held.Some times, the rep was able to get it to move forward by switching from 2d back to 3d.The site was using the hand switch.10 minute delay.No patient impact.(b)(6) 2023 e1 (rep): additional information was received.The probable cause of the issue was a faulty hand switch.
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Manufacturer Narrative
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H3, h6) the (b)(6) lot: 424783 rev.E was returned to the manufacturer for analysis.After functional testing, performance testi ng, and a visual/physical examination, the reported complaint was confirmed.Visual inspection passed.The hand switch was installed into a test imaging system and the system booted and readied.When actuated, the three-dimensional (3d) button would not acquire an image.The two-dimensional (2d) and store buttons were functioning as expected when pressed.The handswitch was faulty.Codes b01, c13, and d02 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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Search Alerts/Recalls
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