Date of event is estimated.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The allegation is against one of two leads; however, it is unknown which lead(s), therefore, all potential components are being listed.Additional components potentially involved in the event: product family: scs, model: 3186, udi: (b)(4), serial: (b)(6), batch: a000125735.The allegation is against one of two anchors; however, it is unknown which anchor(s), therefore, all potential components are being listed.Additional components potentially involved in the event: product family: scs, model: 1192, udi: (b)(4), batch: 8417475.
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