The reported field event of can discoloration was confirmed by inspecting the device when received for analysis.The discoloration marks were analyzed and identified to be the parylene coating that was not entirely removed from the can surface during manufacturing.The anomaly is cosmetic in nature.The device functionality was tested in the lab and was revealed to be normal.Telemetry, pacing, sensing, impedance, high-voltage (hv) output, hv shock, and the patient notifier were all tested on the bench and no anomalies were revealed.
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