Information was received via published literature.Please reference literature at the following location: http://www.Ncbi.Nlm.Nih.Gov/pubmed/1297571.(b)(4).The device was not returned for review, therefore its condition cannot be described.The device history record could not be reviewed as the item/lot numbers are unknown.The device was used in treatment.No applicable patient history is available for review.Compatibility of the devices is unknown.A complaint history review could not be performed with the lack of identifying product information.With the information provided, a definitive root cause cannot be stated.
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