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Model Number UNKNOWN BRAVO |
Device Problems
Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Aspiration/Inhalation (1725); Foreign Body In Patient (2687); Cough (4457)
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Event Date 08/17/2022 |
Event Type
Injury
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Manufacturer Narrative
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Title: foreign body in the bronchus intermedius: inadvertent deployment of a bravo wireless ph probe in the airway source: case report: gastroenterology.Issn: 2691-171x doi: 10.1097/pg9.0000000000000299 jpgn reports (2023) 4:2(e299) received october 21, 2021; accepted august 17, 2022.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 literature study, a case described a 14 year old male who underwent an esophagogastroduodenoscopy with placement of the capsule.Upon deployment of the capsule, the patient began coughing without oxygen desaturation.Repeat endoscopy did not reveal the capsule within the esophagus or the stomach.Patient was then intubated, and fluoroscopy demonstrated a foreign body within the bronchus intermedius.Rigid bronchoscopy was performed to retrieve the capsule using optical forceps.Patient recovered well without tachypnea, coughing, or desaturation.
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Manufacturer Narrative
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Correction: d2 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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Additional information: g3 correction: h6 steven m.Andreoli, md, stefanie schrum, md, and katherine mcgoogan, md.Foreign body in the bronchus intermedius: inadvertent deployment of a bravo wireless ph probe in the airway.Case report: gastroenterology.Issn: 2691-171x doi: 10.1097/pg9.0000000000000299; jpgn reports (2023) 4:2(e299).Pages 1-3 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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