H3.Device evaluated by mfr? code 81 - device evaluation is not necessary because the reported event has been determined to be related to the functionality of the device.Appropriate code/term not available- e2402 used to capture the reported drainage.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.H3 other text : 81.
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It was reported that the patient was first hospitalized and then ultimately explanted due to fever, dehiscence wound, and drainage.No assessment could be provided by physician as to if there was an infection present.Device history records were reviewed for the generator and lead.The generator and lead passed all specifications prior to distribution.The generator and lead were hp sterilized.Device evaluation is not necessary because the reported event has been determined to be related to the functionality of the device.No other relevant information has been received to date.
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