H3.Code 81 - device evaluation is not necessary because the reported event has been determined as not related to vns therapy.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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An implant card was received reporting that the patient had a new vns system implanted due to a previous infection.Follow-up was made and it was reported that the patient was initially seen for a generator replacement due to low battery; however, after the replacement, the patient presented with a fever and sepsis which required antibiotics and explant.No other relevant information has been received to date.
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F10.Adverse event problem: health effect - clinical code, corrected coding.E1713 was incorrectly listed in the initial report h6.Adverse event problem codes: type of investigation, corrected coding.B11 coding was incorrectly listed in the initial report h6.Adverse event problem codes: investigation conclusions, corrected coding.D1002 and d12 coding were incorrectly listed in the initial report.
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