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Model Number FGS-0636 |
Device Problems
Entrapment of Device (1212); Material Fragmentation (1261)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 05/12/2023 |
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 patient complained of mainly constipation and abdominal pain but also has a long-standing history of gerd.A bravo procedure was requested and the capsule was placed in the patient on (b)(6) 2023.Seven days after, the patient had followed up to the physician and was complaining again of abdominal pain and ongoing constipation but had no obstructive or otherwise red-flag symptoms.However, an abdominal x-ray was completed on (b)(6) due to the patient persistent complaints and found a fractured pieces of the capsule that remained within the gi tract.The patient has been using "vibrant" capsules, which are non-medicated capsules being swallowed 5 out of every 7 days that were meant to emit vibrations in the colon to aid in peristalsis to help relieve constipation.The patient did not see the capsule pass in the stool.There was no reported patient outcome.
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Manufacturer Narrative
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Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned but according to phys ician¿s collaboration, after reviewed and analysis of the x-ray, it was noted that the metallic objects were pieces of the vibrant capsules (non-medicated capsules the patient swallows 5 out of 7 days which emit vibrations in the colon to aid in peristalsis to help relieve constipation).There is a low likelihood these metal objects are related to the bravo.It was reported that the capsule remained in the patient longer than expected and the capsule broke apart in the patient's body.The reported issues could not be confirmed.The most likely cause was not traced to the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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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