Model Number BI70002000 |
Device Problems
Communication or Transmission Problem (2896); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
Radiation Exposure, Unintended (3164)
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Event Date 06/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: kit svc o2 bi71000517, o-arm sw 4.0.1 usa, software version # unknown.No products have been returned to medtronic for analysis.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 used during a sacroiliac and thoracolumbar procedure.It was reported that the system performed an incomplete scan, and the images appeared collimated superiorly.The scan contained 94 slices and did not transfer to the navigation system giving incomplete transfer error message.There was a reported delay to the procedure of less than one hour.There was no reported impact to the patient.
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Manufacturer Narrative
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Concomitant medical products: information references the main component of the system.Other relevant device(s) are: product id: bi-500-01065, software version #: 4.0.1 software analysis was performed, and it was determined that this is a known issue.Previously reported code 10 is applicable, as are codes 104 and 4307.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: it was reported that there was 1 unused partial spin.There was no issue with image quality.The radiologic technologist didn't execute a collimated scan.The representative initially described the scan as looking ¿collimated¿, as it appeared collimated from top to bottom (superior/inferior).This is not possible with the system.The representative has since then spoke with our field service engineer and he suspects that the image reconstruction process, that takes place after the spin, didn't fully reconstruct the scan possibly due to the rad tech moving the gantry while the images are in reconstruction process.It was reported that the scan contained 94 slices out of 192.
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Manufacturer Narrative
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Onsite functional and visual examination was performed by a manufacturer representative.The system passed a system checkout and was determined to be operational.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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Manufacturer Narrative
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H2: additional information was received: per sop-cpa-05, it was determined there was an accidental radiation occurrence due to early termination of acquisition.No defect in an electronic product or failure to comply per 21 cfr 1003 was discovered.The o-arm log investigation concluded the system had a known recoverable software issue.This issue is not a systemic as it was resolved by retaking another image or system reboot.Estimated 3d dose absorbed (patient): 11.21 msv dinglm2 (b)(6)2020: number of people exposed: 1 - patient number of people in or other than patient: 0 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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