Per bio-libra study, subject went to the er for abdominal/diaphragm pain which the subject believed was related to their device.The subject had not received any therapy from the device and was sent home only after a couple hours.An office visit was scheduled to check their device.After reviewing the report it appears the pain could have possibly been from pns.As a result, a few settings were changed on the subjects device.Device remains implanted.No adverse patient events were reported.Should additional information become available, this file will be updated.
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