There was no patient involvement.This event was initially considered to be non-reportable.However, after additional evaluation, livanova (b)(4) has decided to reclassify this event as reportable.This report is being filed as part of a retrospective review conducted in response to this new decision.Livanova (b)(4) manufactures the electrical venous occluder (evo).The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The complaint was not confirmed and not reproducible on site.The device was replaced with a customer replaceable unit.As the issue was not reproduced, a root cause could not be determined.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.Device not returned.
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