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Model Number FGS-0499 |
Device Problem
Entrapment of Device (1212)
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Patient Problems
Inflammation (1932); Foreign Body In Patient (2687)
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Event Date 02/20/2023 |
Event Type
Injury
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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.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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According to the reporter, the capsule has been in the patient stomach for 6 weeks.Notes from the medical advisement team, negative egd and colon.Small bowel imaging showed chronic enteritis and with suspected crohns decease.The report did not show any mucosal evidence of crohn's in the capsule and it did not pass into the cecum on the video.A follow up x-ray showed the retained capsule in what was initially read as the descending colon.Ct scan on follow up showed location of the capsule to be in the small intestine.Patient initial symptoms were improving on "budesonide", which was started 4 weeks ago for capsule inflammation and had no signs of obstruction.Patient was doing better and clinically not obstructed.The capsule has not passed.Patient was followed closely with serial exams and imaging.
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Manufacturer Narrative
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Additional information: 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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According to the reporter, the capsule has been in the patient stomach for 6 weeks.Notes from the medical advisement team, negative egd and colon.Small bowel imaging showed chronic enteritis and with suspected crohn's decease.The report did not show any mucosal evidence of crohn's in the capsule and it did not pass into the cecum on the video.A follow up x-ray showed the retained capsule in what was initially read as the descending colon.Ct scan on follow up showed location of the capsule to be in the small intestine.Patient initial symptoms were improving on "budesonide", which was started 4 weeks ago for capsule inflammation and had no signs of obstruction.Patient was doing better and clinically not obstructed.Several exams and imaging was closely followed.The capsule has not passed but the patient was stable.
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Search Alerts/Recalls
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