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Model Number 1000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dysphagia/ Odynophagia (1815); Headache (1880); Paresis (1998); Suicidal Ideation (4429); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/17/2023 |
Event Type
Injury
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Event Description
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The patient reported experiencing trouble digesting food, no gag reflex, throat pain, headaches, stomach bloating, emesis, groin pain, nausea and choking sensation and related all events to the vns.The patient's settings were lowered but this did not resolve the symptoms.The patient reported suicidal ideations in the past due to the adverse events they experienced.The patient's device was checked and all values were within normal limits.The patient's device was then disabled and they were referred for an eeg.No other relevant information has been received to date.
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Manufacturer Narrative
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Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees 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 "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.F10 health effect, clinical code: code e2402 utilized; appropriate term ¿dyspepsia ¿ is not available.Health effect - clinical code :e1032.Health effect - clinical code :e1020.Health effect - clinical code :e2311.Health effect - clinical code :e2311.Health effect - clinical code :e2402.
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Event Description
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Additional information received noting that the patient was seen by a physician who diagnosed him with gastroparesis.The patient also reported that they have developed a stomach infection.The patient noted they were hospitalized.No other relevant information has been received to date.
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Manufacturer Narrative
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F10 health effect, clinical code: code e2402 utilized; appropriate term ¿stomach infection¿ is not available.
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Search Alerts/Recalls
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