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Model Number FGS-0636 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Date 02/21/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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According to the reporter, the capsule placed to the patient successfully.After waking, the patient reported pain rated as 8 of 10 in two locations, mid-esophagus and epigastrium.Patient was given viscous lidocaine and interested in having capsule removed.No known history of metal allergy.There was no serious injury or harm to the patient.
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Search Alerts/Recalls
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