Visual inspection of the paddle revealed a number of locations with surface damage on the paddle splines.Electrodes 1, 6, 14 and 16 read as open circuits.Dissection revealed conductor wires 1, 6, 14 and 16 had been fractured proximal to the weld joints, consistent with the open circuits detected and the reported signal issue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured conductor wires and paddle damage is consistent with damage during use.
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