It was reported that the patient coded (not related to vns) which resulted in performing cardioversion.The physician had concerns of nerve damage after this and wanted to have the device checked to ensure it was functioning properly.A system diagnostics was performed and all values were within normal limits.It was reported that at least one of the pads used during cardioversion was placed within 1 inch of the generator.Per the physician, right after the cardioversion, the patient began experiencing numerous symptoms that she felt may be indicative of damage to the vagus nerve as a result of the cardioversion, including tachycardia.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 livanovas 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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