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 had an explant due to inability to tolerate stimulation even at low doses.Additional information from the physician was provided.Per the physician, only the generator was explanted.Regarding the report of inability to tolerate stimulation, the physician noted that the vns had been off for sometime.In addition, the explant was done for patient comfort only.The suspect device has not been received to date.No other relevant information has been received to date.
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