Date of event is estimated.The allegation is against 1 of 2 leads; however, it is unknown which lead(s), therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: lead, model: 3186, udi: (b)(4), serial: (b)(6), batch: a000090720.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.
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