The patient developed daily vomiting in the morning 2.5 years after the vns was implanted.The patient was given medication but there was no improvements seen.It was also reported that the patient was experiencing dysphagia, coughing and weight loss.The patient had lost over 20 % of her total body weight and was at risk of associated adverse health effects; after thorough gi workup, she was not felt to have a primary eating disorder.Her vns output current and magnet current were reduced to 1.25 ma and 1.5 ma, respectively, due to her coughing and dysphagia, but there was no improvement in her vomiting with this adjustment.Once the patient's device was disabled, there was immediate cessation of her vomiting and a dramatically rapid recovery of weight over the next few months.No other relevant information has been received to date.
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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.Health effect - clinical code :e1208.
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