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.
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It was reported that the patient started experiencing dysphagia, and continuous hiccups.Mother also noted that the patient experienced a fever where they were admitted to the hospital.Admission to the hospital found that the patient had pneumonia due to aspiration.Additional information was received noted that the patient's device setting was decreased.More information was received noting that the magnet was tapped overnight which stopped the hiccups but restarted after removing magnet after eating breakfast.Device was temporarily turned device off for 20 minutes but hiccups did not stop.Patient was then referred for x-ray, and increase in medication to induce sedation.Physician is noted to not be certain whether the hiccups are vns related or not.No other relevant information has been received to date.
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