Earl E. Bakken, an electrical engineer who built the first wearable, battery-powered pacemaker in the 1950s, an innovation that helped save millions of lives and set his company, Medtronic, on a path to become one of the world’s leading manufacturers of medical devices, died Oct. 21 at his home on Kiholo Bay in Hawaii. He was 94.
His company announced the death in a statement but did not cite a cause.
Mr. Bakken and a brother-in-law co-founded Medtronic — the name was formed by combining the words “medical” and “electronic” — in a Minneapolis garage in 1949. In their early years, they repaired TV sets as well as hospital equipment to keep the business afloat.
By 2017, Medtronic had annual revenue of more than $29.7 billion, according to the company. Its product line today includes an array of medical devices, among them insulin pumps, cardiac stents and deep brain stimulation systems. But for years it was best known for pacemakers, which deliver electrical impulses to damaged hearts to maintain normal rhythm.
Mr. Bakken had been captivated by electricity since his youth when he watched “Frankenstein,” a cinematic rendering of Mary Shelley’s story about the scientist Victor Frankenstein, who animates a monster with jolts of electricity. Mr. Bakken realized, he once told the publication World and I, that “when electricity flows, we’re alive. When it doesn’t, we’re dead.”
In the early years of his business repairing hospital equipment, Mr. Bakken met C. Walton Lillehei, a physician at the University of Minnesota who became known as a father of open-heart surgery.
Lillehei asked for Mr. Bakken’s help after losing a patient, an infant suffering from “blue-baby” syndrome, during a power outage on Halloween 1957. The baby had been hooked up to a pacemaker, which at the time was a large apparatus connected to a wall socket. What was needed, Lillehei said, was a smaller machine that ran on battery power.
Mr. Bakken recalled a design he had seen in Popular Mechanics for a metronome, a device that emits steady clicking sounds to assist musicians in keeping time during practice sessions. The design could be modified, he realized, to mimic the steady beating of a heart.
“What we had was a small, self-contained, transistorized, battery-powered pacemaker that could be taped to the patient’s chest or bed free of any chords and AC connections,” Mr. Bakken later recalled, according to Investor’s Business Daily. “The wires that carried the pulse to the heart could be passed through the patient’s chest wall.”
At the time, the Food and Drug Administration did not yet have regulatory oversight over medical devices. (Congress would not extend that authority to the agency until 1976.) Mr. Bakken tested his device on a dog and, the next day, found Lillehei using it on a human patient at the hospital.
“Here he had this pacemaker wrapped to a child,” Mr. Bakken told the Minneapolis Star Tribune in 2007. “That was quite an emotional moment in my life to see a child being kept alive by something we had made with our own hands.”
Joseph P. Drozda Jr., a cardiologist and the director of outcomes research at Mercy Health systems in St. Louis, called the advent of Mr. Bakken’s pacemaker a “seminal event in cardiology.”
Shortly thereafter, another electrical engineer, Wilson Greatbatch, and a collaborating surgeon, William Chardack, developed a pacemaker that could be implanted in a patient’s body. In 1960, Medtronic won the license to manufacture the new devices, which further revolutionized cardiac care.
Mr. Bakken often cited Medtronic’s founding mission — to “alleviate pain, restore health and extend life” — and told the New York Times that a subsidiary of the company once declined a proposed contract to produce bomb fuses.
“We will not take that kind of business,” Mr. Bakken said in 1976, the year he stepped down as chief executive. “We’re helping man, not destroying him.”
Medtronic, which operated at the sometimes dangerous intersections of medicine and profit, innovation and technological fallibility, at times faced scrutiny for the safety of its products. In 1976-1977, the company recalled more than 35,000 Xytron pacemakers, according to Forbes magazine, after their batteries were shown to fail when moisture leaked into the device.
More recently, Medtronic agreed in 2010 to pay $268 million in a settlement involving Sprint Fidelis internal defibrillators, which had faulty wires that the company conceded “may have been a possible or likely contributing factor” in the cases of 13 patient deaths. In 2007, the company paid more than $114 million in a settlement involving the Marquis defibrillator, which suffered from defective batteries.
Earl Elmer Bakken was born in Minneapolis on Jan. 10, 1924. His parents cultivated his curiosity by allowing him to play not only with Erector Sets and other toys but also with hardware parts such as copper wire and vacuum tubes.
He built robots as a child — including one that even smoked cigarettes — and a phone system that connected his house to one nearby. He also recalled rigging the high school loudspeaker system so that students could hear President Franklin D. Roosevelt call for a declaration of war on Japan after the Pearl Harbor bombing in 1941.
Mr. Bakken served in the Army Signal Corps during World War II before receiving a bachelor’s degree in electrical engineering from the University of Minnesota in 1948. His brother-in-law and Medtronic co-founder, Palmer Hermundslie, ran a lumber yard before the two men opened their business.
“One night at a family party we just decided that we would quit what we were doing,” Mr. Bakken told the Times, “and start a business servicing medical electronic equipment.”
Mr. Bakken moved to Hawaii after he retired as chairman of Medtronic in 1989.
Mr. Bakken’s first marriage, to Connie Olson, ended in divorce. In 1982, he married Doris Marshall. Besides his wife, who resides on the island of Hawaii, survivors include four children from his first marriage, Wendy Watson of New Brighton, Minn., Jeff Bakken and Bradley Bakken, both of Orono, Minn., and Pamela Petersmeyer of Prior Lake, Minn.; two stepchildren, Ramona West of Waikoloa, Hawaii, and David Marshall of Rice, Minn.; a sister; 14 grandchildren; and eight great-grandchildren.
As a patient, Mr. Bakken was outfitted with an insulin pump, heart stents and two pacemakers by Medtronic.
“I’m glad I invented the company,” he told the St. Paul Pioneer Press in 2010, “or I wouldn’t be sitting here.”