Device evaluated by mfr? code 81 - device evaluation is not necessary because the reported event has been determined to be related to the implant procedure.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 since their implant surgery the patient has lost their gag reflex, is unable to swallow, and they have a left vocal cord palsy.The patient had been reviewed by an ent doctor and had their device switched off.Device evaluation is not necessary because the reported event has been determined to be related to the implant procedure no other relevant information has been received to date.
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