When medical implants fail

A cardiac defibrillator - called an ICD - which was recalled by its manufacturer.

Statistically, fewer than one percent of all medical devices fail their patients - far fewer, in fact. Small comfort if one of those very rare failures strikes you or me or someone you love. Our Cover Story is reported by Jim Axelrod:

Joshua Oukrop was 21 when he died seven years ago of a heart attack. Robert Hauser is not a relative; he was Joshua's cardiologist.

"How often do you think of Joshua?" Axelrod asked.

"Every day," Dr. Hauser replied. "He was young. It shouldn't have happened. It just shouldn't have happened."

The story of what happened to Joshua begins with the discovery as a teen that he'd inherited a heart condition from his father, Lee.

"He came home from band and his saxophone was dented in a little bit in a few spots," Lee Oukrup said. "And he said, 'I just passed out and fell forward.' So we knew something had to be done."

Josh's parents took him to see Dr. Hauser at Abbott Northwestern Hospital's Minneapolis Heart Institute. Hauser decided to implant a cardiac defibrillator - called an ICD - in Josh's chest.

"When the heart becomes very chaotic, it shocks the heart back to normal," Dr. Hauser said.

Although Lee Oukroup and his older son, Jacob, both had similar heart conditions, neither had shown signs of disease. So only Joshua had an ICD implanted.

"He was a kid, you know? He was a little reluctant to do it, but he knew it was for the best," Lee said.

Three years of routine tests and check-ups went by uneventfully. And then, in March 2005, Joshua Oukrop took a biking trip in Utah with his girlfriend.

"His girlfriend saw him fall off his bike and collapse," Dr. Hauser said. "CPR was attempted but he could not be resuscitated. . . . He died."

Lee Oukroup said the county coroner told him that Joshua's ICD was faulty. Instead of shocking Josh's heart back into rhythm, the device had shorted out.

Josh's doctors asked Lee for permission to remove Josh's heart and examine it: "I tell you, it was a very, very hard thing for me to do. I wanted my son whole. But I agreed to do it and they brought it back to Minneapolis and they autopsied just the heart itself. And they found out that it was a very shockable heart. He could have been brought back to life had the device worked."

"Had the device worked ..." Crushing words to Dr. Hauser, and intense motivation as well. How could the device have not worked?

"I got into the FDA database," Dr. Hauser said. "And my search uncovered a number of problems." He found the ICD's manufacturer, Guidant, had known the defibrillator was faulty since 2002.

"We eventually met with Guidant in May of 2005," Dr. Hauser said. "This would be three months after Joshua's death, and we told them they were obligated to inform patients and physicians of the problem."

"What did they say to you?" Axelrod asked.

"They declined to do so. They stated that they were afraid physicians would overreact and take these devices out unnecessarily, because they believe that the likelihood of failure was very low."

Dr. Hauser said that, as a result, tens of thousands of people were walking around with a faulty defibrillator.

So he told his story to The New York Times: "That defibrillator was recalled," he said.

Guidant was taken over by Boston Scientific, which declined to comment, saying it was "not interested in participating" in our report.

But that's not the end of the story.

Dr. Hauser kept digging. He says he found problems at the FDA - the agency charged with approving and overseeing medical devices. He believes both the approval process and the follow-up once devices hit the market are badly flawed.

"In this whole episode, where was the FDA the whole time?" Axelrod asked.

"I don't know," Dr. Hauser said. "The FDA should have been on top of this, because Guidant had filed a report with the FDA in August of 2004 laying out the details of the problem with the device."