Part of a defibrillator that’s surgically implanted has turned out to be defective.
A man who has one in his chest is suing, WESH 2 News reported. He doesn’t know if the medical device inside him, will kill him. "It just scares me," patient Tom Kern said. "I’m 75. I’d like to be 76 someday."
Kern went to a doctor for an irregular heart beat, had a Medtronic defibrillator put in, and days later the company issued a recall for that product. "Two weeks later, I see on television they’re having trouble with it and it could zap me," Kern said. The reason it’s been recalled is that its jolts of electricity aren’t always reliable.
The defibrillation system consists of an electronic device implanted near the shoulder containing one or more leads, and it’s the lead or wire connecting from the defibrillator to Kern’s heart that can crack. "The wire could break and zap me unnecessarily, or worse than that, if I needed it, it might not zap me," Kern said.
"He’s walking around like a ticking time bomb and if the lead wire does fracture, he might not survive that heart attack," attorney James Frazier said. Frazier is filing a civil lawsuit for Kern against Medtronic.
He believes the company knew about the problems months before the recall. In fact, Frazier said Medtronic even sent letters to doctors this spring warning about the unexpected risks.
"We’re looking for Medtronic to be held accountable. They knew that this was a defective product," Frazier said. Medtronic said it’s more dangerous to take out the lead than leave it in, leaving patients like Kern heartbroken over what to do to survive. "What’s the worst of two evils — to die on the street or die on the table?" Kern said.
Medtronic said there are about 235,000 of these leads in patients right now, and they said the problems could have led to five deaths.
The model is called the Medtronic Sprint Fidelis Lead, and the model number will include one of these sets of numbers: 6930, 6931, 6948, and 6949. Patients who have one should call their doctor immediately.
Their options are to leave the lead alone and monitor it, cap the wire and put in a new one, or replace it.