The investigation of this event is ongoing.Additional information has been requested from the site regarding event details, causality, device information, and physician opinion.The information has not yet been received.A supplemental report will be submitted when the investigation is complete.Csi id: (b)(4).
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Updated data: b4, g3, g6, h2, h6, h10.The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.The device history record for this device could not be reviewed since the lot number was not provided.Csi id: (b)(4).
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