Patient information was not provided.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.The incident occurred in (b)(6).Livanova (b)(4) was providing technical support and it was suggested to replace the enc board or to send the device to the manufacturer for further investigation.No more information was provided by the customer.The device hasn´t been sent to livanova (b)(4) for investigation and therefore the root cause could not be determined.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Device not returned.
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