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Model Number FGS-0636 |
Device Problem
Entrapment of Device (1212)
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Patient Problems
Pain (1994); Foreign Body In Patient (2687); Constipation (3274); Unintended Radiation Exposure (4565)
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Event Date 09/02/2020 |
Event Type
Injury
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Manufacturer Narrative
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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 was embedded in the customer to record acid reflux.Patient experienced a lot of pain a few weeks after the procedure.A cat scan was issued to the patient and report came back as normal.Patient still experienced pain in the abdomen and saw the patient physician twice and ordered an ultrasound and came back as normal and still having pain in the left side groin area and constipation.Another cat scan was issued and showed a foreign object in the colon that looked like fish bone.A sigmoidoscopy was performed and could not find anything.Patient met their surgeon and recommended no surgery at that time since the delivery system and the monitor were embedded in the colon and believed surgery was not an advantage.
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Event Description
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According to the reporter, the capsule was embedded in the customer to record acid reflux.Patient experienced a lot of pain a few weeks after the procedure.A cat scan was issued to the patient and report came back as normal.Patient still experienced pain in the abdomen and saw the patient's physician twice and ordered an ultrasound and came back as normal but still having pain in the left side groin area and constipation.Another cat scan was issued and showed a foreign object in the colon that looked like fish bone.A sigmoidoscopy was performed and could not find anything.Patient met their surgeon and recommended no surgery at that time since the delivery system and the monitor were embedded in the colon and believed surgery was not an advantage.Currently, the patient had a pain in left part of the colon.The rate of pain was 2 on 1-10 scale.
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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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Search Alerts/Recalls
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