Correction h6 results and conclusion code.The reported event could be not be confirmed.The device remains implanted and no other evidences were provided that could confirm the allegation.The opinion of the medical expert was requested and stated as following: ¿this axillary nerve dysfunction, that leads to a deltoid muscle weakness is indeed an ae that is not device related yet related to the surgery.Usually it¿s neuropraxia (traction injury without loss of structural nerve continuity) and will resolve spontaneously, but sometimes it doesn¿t, or it doesn¿t completely when the nerve is damaged more severely.It will become clear during follow up.Sometimes electrophysiological investigation, assessing the conduction velocity of the nerve(s) at 6 weeks after the problem started, may provide a recovery prognosis.¿ a device inspection was not possible since the affected device was not returned as it remains implanted in the patient.A review of the labeling and the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.More information as well as the affected device must be available in order to determine the exact root cause of the alleged failure.If any additional information is provided, the investigation will be reassessed.
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