It was reported that a case study on a vns patient revealed that the patient developed hiccups.It was noted that despite medical treatment, the hiccups persisted resulting in a mallory-weiss tear requiring intensive care unit (icu) admission with intubation and ventilation followed by a month-long rehabilitation.The patient then underwent a nissen fun doplication followed by two phrenic nerve blocks that led to only transient hiccup resolution for 13 months.Finally, the vns was turned of, which was followed by complete hiccup resolution.No other relevant information has been received to date.
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This file is not considered late, as initial report was attempted to be submitted 09/05/2023, but was delayed due to esg issue.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 39; 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 34; defects¿ or 34; malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.
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