At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.The header was firmly attached to the pg casing.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Under-insertion of the lead terminal pin into the device header is suspected to be the cause of the difficulty inserting an is-1 plug into the atrial pot, but this could not be confirmed during laboratory analysis.The root cause of the lead insertion difficulty could not be confirmed during laboratory analysis.Note that boston scientific has a vigilant quality monitoring system and we aggressively monitor field performance of all our products.We will continue to monitor for similar events.
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