Due to limited information, this event is being reported in a conservative manner.The manufacturer is currently in the process of receiving further information from the physician on this event.Manufacturing site is unknown as the serial number is not yet known.Livanova (b)(4) corp is listed for this report for the manufacturing site but could also be the sister site, (b)(4).Device manufacture date and date of expiry is unknown as sn# is not yet known.Not yet determined if device available.
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Multiple attempts have been made by the manufacturer in contacting the physician to gather further information on this event.No further information has been provided.The device is not available for return or analysis (not explanted), nor is the serial number known.No further investigation can be completed at this time.Manufacturing site is unknown as the serial number is unknown.Livanova canada corp is listed for this report for the manufacturing site but could also be the sister site , (b)(4), it device manufacture date and date of expiry is unknown as sn # is not known.Not available for return.
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