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 by the caregiver of the patient that the patient had experienced several adverse events.They had stated that the vns stimulation had felt erratic and caused, vomiting, and vomiting blood.Additionally they report that the vomiting had resulted in a hernia.The device was first disabled and then ultimately explanted.The leads were left implanted.No other relevant information has been received to date.The suspect product has not been received to date.
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