The warnings in the package insert state this type of event can occur.Without a product return, no product evaluation is able to be conducted.The lot history of the implanted unit is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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