If we ask them to tell us every single time any device doesn't meet specifications, we'll be flooded with data. If we set the bar too high, we'll miss information about malfunctioning devices.

In contrast, if he gets a shock from the device -- and this device can deliver the shock much like you see on (the television show) 'ER' or something with paddles on the chest, the device does it from inside the heart -- then that is something that he will feel, and patients describe it anywhere from a giant hiccup to a mule kick in the chest,

We just haven't experienced that.

Cardiology is germane to the administration,

Should the heartbeat get too slow, it will pace it to make it go faster. If the heartbeat gets too fast, it will act to slow it down. The patient needs not think about this at all,

It's gotten so that we keep waiting for the other shoe to drop,