Tuesday, November 11, 2008
Medical Reports: Sudden Shock
It was a device they were told could save their lives, but now some heart patients are living in fear that something they had surgically implanted in their body may be doing more harm than good. Seven's Craig Stevens has our special assignment report Sudden Shock.
WSVN -- Cynthia Turner was alone, driving down Interstate 95, the first time she received a body-rocking shock.
Cynthia Turner: "All of a sudden, it was like lightning came and bam, my whole body jumped. I had to hit the brakes really fast."
She'd recently had a defibrillator implanted to kick start her heart into perfect rhythm, but now it was striking her with electrifying force.
Cynthia Turner: "They told me I was going to get shocked, but I didn't think I was going to get shocked like I got hit by a train."
Frank Almarez was changing a tire when he says he got not one but three unexpected jolts.
Frank Almarez: "It felt like I had stuck my hand in a light socket. I backed away from my car, and it hit me again, and the third time it was so intense it knocked me to the ground."
Frank and Cynthia are among hundreds of thousands of heart patients who have learned the lead wires that connect the defibrillator to their heart can malfunction.
The lead wires can fracture and fire off unnecessary shocks, or worse, not operate at all when the patient's heart really needs a shock. The brand of lead wire involved is call Sprint Fidelis, and it's manufactured by Medtronic.
In 2007, Medtronic voluntarily stopped distributing the lead wires but recommended, in most cases, leaving them in the patient's body.
Cynthia Turner: "I'm like walking around like a time bomb ready to explode."
At that same time, the FDA said: "Some deaths and major complications have occurred after the leads have fractured."
But in an email to Seven News, Medtronic says they too have investigated the deaths, and the "information available to us is insufficient to draw conclusions".
Medtronic also points out that lead fractures happen at a low rate, and most patients will never experience problems.
Dr. Myerburg, UM Miller School of Medicine: "It's been quite well proven that the benefits of defibrillators, in terms of saving lives, is much greater than the downside of defects."
The issue for people with these recalled devices inside them is what to do next. In a letter to patients, Medtronic said: "Doctors may choose to change the way a device is programmed to help reduce any potential problems."
Cynthia Turner: "They are going to keep it in me because it's too much a problem to go back into me to change it."
Cynthia and Frank both had their devices reprogrammed, but they worry the leads could malfunction again, and they say nothing can erase what they've gone through.
Frank Almarez: "I feel like I'm a Guinea pig. This company should take care of my medical bills that I have incurred since this has happened."
But attorneys tell us the U.S. Supreme Court has issued a decision, which makes it difficult for patients like Frank to get compensation.
Bob Brown, attorney: "Quite frankly, every consumer who uses a medical device needs to be aware of this problem, needs to be aware of the immunity of these companies."
Attorney Bob Brown has hundreds of potential cases involving the recalled Medtronic leads. He can't go to court with them because the Supreme Court upheld a federal law, which says companies that make medical devices cannot be sued once the FDA has approved their device for market.
Debbie Wasserman Schultz: "Congress needs to change the law, so that we can make sure that consumers have the right to sue a manufacturer, particularly when it's clear that there was a flaw in the device."
As for Cynthia and Frank, they just want justice and a life without worry about getting another sudden shock.
Frank Almarez: "To be honest, it's been the worst thing to ever happen to me."
Doctors stress these devices save more lives than they endanger and that a fracture is rare. Medtronic has also just came out with an alert system that's supposed to make an audible sound if there is a potential lead fracture.