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Model Number FGS-0312 |
Device Problem
Failure to Transmit Record (1521)
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Patient Problems
Chest Pain (1776); Pyrosis/Heartburn (1883)
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Event Date 05/23/2019 |
Event Type
malfunction
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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 patient complained that the receiver beeped when he experienced two occasions of chest pain immediately after drinking cold water and regurgitation that caused prompt throat irritation.During exercise, the heartburn was very noticeable with a mild throat irritation.Also, the patient noted that the recorder turned off.The transmission of the capsule to the receiver was weakened or paused when the patient marked the symptoms.There was no intervention required because of the issue and no repeat procedure.A lubricant was used to facilitate capsule placement.The recorder worked correctly during the previous procedure.There was no patient injury.
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Manufacturer Narrative
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Evaluation summary: this report is based on information provided by post market vigilance investigation personnel.The product sample was not returned to the medtronic laboratory; however, a pdf files was provided by the customer for analysis.The customer reported the patient complained that the receiver beeped when he experienced two occasions of chest pain immediately after drinking cold water and regurgitation that caused prompt throat irritation.The investigation of the returned equipment did not identify anything that would have caused or contributed to the reported event.Based on the information provided, it is impossible to investigate.The investigation could not determine a root cause or a probable root cause for the customer's report based on the information provided.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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