computer, and gave firm foundation for the modernization of medicine
and the implant revolution.
Earl Bakken designed a two-transistor circuit and enclosed it in a crude
aluminum box that was only four-inches-square and an inch-and-a-half-
thick—about the size of a small stack of coasters or a deck of cards.
Instead of multiple controls like the Grass Stimulator, there was only an
on/off toggle switch and pulse rate and current output rheostats. On top of
the unit were the exposed terminals to connect the wires to the patient, and
inside was housed a powerful 9.4-volt mercury battery. The wires that
emanated from the device were designed to pass through the skin and into
the heart, so that when they were not needed they could simply be
withdrawn at the patient’s bedside.
Four weeks of experimentation yielded a device that was fit for
experimentation at the university’s animal lab, and a single day of trialing
in dogs raised expectations that refinement could lead to a device that
could be implanted in a human. In his autobiography, Bakken recalls
returning to the hospital the very next day to work on another project, and
“I happened to walk past a recovery room and spotted one of Lillehei’s
patients. I must have done a double-take when I glanced through the door.
The little girl was wearing the prototype I had delivered only the day
before! I was stunned. I quickly tracked down Lillehei and asked him what
was going on. In his typical calm, measured, no-nonsense fashion, he
explained that he’d been told by the lab the pacemaker worked, and he
didn’t want to waste another minute without it. He said he wouldn’t allow
a child to die because we hadn’t used the best technology available.”^13
I am gobsmacked when I consider that an American surgeon was able to
implant a device in 1957 without any FDA device clearance, but none
existed at that time. The 1950s was the Wild West of device development,
with no laws and no sheriff. While it was personally risky for Lillehei and
Bakken to implant a “MacGyver” implant, it wasn’t against the law. Today
you would quite literally go to jail for such an offense. But in 1957,
medical devices were about heroic gallantry and optimism, and the
ambulance-chasing enterprise of personal injury law was yet to be born.
The world’s first battery-powered, wearable cardiac pacemaker had
come about from a confluence of new transistor and polymer technologies,
and the evolution of batteries and new coating materials, and the prepared
mind of Earl Bakken. What was the name of Earl’s struggling little