F10 health effect, clinical code: code e2402 utilized; appropriate term ¿increased phlegm production¿ is not available 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 :e0712.Health effect - clinical code :e2402.
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It was reported that the patient is experiencing pain in the neck, generator site and throat.It was also noted that the vns causes coughing attacks and increased phlegm production.It was noted that the patient is also experiencing pain in the throat/neck region, and at the generator implant site.Mother decided to continue with the device being explanted due to these adverse events additional information was received noting that the device has been explanted explanted device has not been received to date.No other relevant information has been received to date.
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