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FDA 678 articles

Safety concerns over defibrillator wires

Shares of medical device maker St. Jude Medical could face pressure Monday on a media report that raised safety concerns over some of its defibrillator wires. The Wall Street Journal reported Monday that in rare instances, the company’s Riata line of defibrillator leads are poking holes through the hearts of cardiac patients rather than remaining attached to the heart wall. The leads connect a patients heart to an implantable defibrillator, which helps maintain a proper heart rhythm. The cases have been reported to the Food and Drug Administration. The newspaper said the most recent cases involve the accounts of four ... Read More

Confusing new warning label on Avandia

If you take the popular diabetes drug Avandia, you should take notice at the new warning label. The FDA has strengthened the warning label on Avandia to include an increased risk for heart attack. But it may be a little confusing. Officials say the warning label will say that Avandia “may or may not” increase their risk of heart attack. The reason is that while short term studies have linked Avandia to an increased heart attack risk, longer term studies have been inconclusive. In the meantime, experts suggest that people with heart disease take something other than Avandia. November 15th, ... Read More

A patient an advocate a fixer

When it comes to her health, Laurel Lewis is positively fearless. The 54-year-old Minneapolis woman has stared down a rare breed of late-stage cancer. And last year, she technically died after her heart stopped beating, but luckily her near-fatal attack occurred just outside Fairview Southdale Hospital in Edina. She left the hospital with an implantable cardioverter defibrillator (ICD) made by Medtronic Inc. tucked inside her chest, a kind of medical-device insurance policy intended to shock her heart back into rhythm if she goes into sudden cardiac arrest. “I have faced the darkest day,” she said recently. But on Oct. 15, ... Read More

Common MRI poisoning some kidney patients

If she knew then what she knows now, Sarah Fracella would not have undergone an MRI. “I don’t think there’s been a day in the last, probably, two years that’s gone by that I haven’t cried at least once about this,” said Fracella, 38, of Santa Barbara, whose skin is hardening painfully into something that looks startlingly like marble. Fracella is one of as many as 1,000 people worldwide who have contracted a debilitating, incurable and sometimes fatal disease called nephrogenic systemic fibrosis, or NSF, from the dye that is used in millions of magnetic resonance imaging scans every year. ... Read More

Defective Medtronic Sprint Fidelis lead fracture reports ignored by company

Medtronic Inc. knew that its Sprint Fidelis Defibrillator Leads were fracturing at higher-than-usual rates for months. Yet, the company appears to have dragged its feet in getting the defective Sprint Fidelis Lead off the market. Medtronic even went so far as to blame physicians for the problems, claiming that they weren’t implanting the defective Sprint Fidelis Lead properly. What’s even worse, the Food & Drug Administration (FDA), which never required the defective medical device to undergo clinical testing, was oblivious to the increasing reports of Sprint Fidelis Lead problems. Medtronic suspended sales of the Sprint Fidelis Leads in October, after ... Read More

Gadolinium contrast agents used off-label in MRAs pose even greater risk

Gadolinium based contrast agents used during MRIs, are known to be associated with the onset of Nephrogenic Systemic Fibrosis/ Nephrogenic Fibrosing Dermopathy (NSF/NSD) in patients with pre-existing kidney disease. But the use of gadolinium in a procedure call Magnetic Resonance Angiography (MRA) could put these patients at an even greater risk of developing NSF/NSD, because these procedures often use far more gadolinium than a typical MRI. The use of gadolinium contrast agents in MRAs is a growing practice, even though the Food Drug Administration (FDA) never approved gadolinium for MRAs. An MRA is a variation of a traditional MRI that ... Read More

Patients concerned about Medtronic Sprint Fidelis leads

Patients who have been implanted with [Medtronic Sprint Fidelis Leads] are understandably concerned after learning that the leads have been linked to five fatalities. Some patients have undergone risky surgeries in order to have the leads removed after they malfunctioned. Meanwhile, [lawsuits] have been filed on behalf of patients who were injured by fractured leads. The leads were implanted into hundreds of thousands of patients who are now at risk of serious injury if their Sprint Fidelis Lead malfunctions. All unused leads were recalled by Medtronic on October 15, although Medtronic is actually referring to the recall as a “voluntary ... Read More

NorCal man blames MRI dyes for illness

An elderly man has sued several major health companies, claiming the dyes used to scan his failing kidneys caused a rare, painful and incurable disease. Peter Gerber, 72, of San Rafael, contends that injections of dyes containing the heavy metal gadolinium caused him to develop nephrogenic systemic fibrosis, or NSF. Also known as nephrogenic fibrosing demopathy, the disease can thicken the skin, stiffen joints, restrict movement and potentially lead to death if it affects internal organs. Only about 215 cases have been reported worldwide, all involving people with kidney disease. No cures have been reported but some patients have seen ... Read More

Medtronic recall exposes gaps in medical safety

In late January, something unsettling happened at the Minneapolis Heart Institute. On two successive days, patients came to the clinic after their heart defibrillators had jolted them with huge, unnecessary and painful electric shocks. One 65-year-old woman said she’d been zapped 14 times in an hour. Doctors checked the hospital’s records and discovered four similar cases had occurred in recent months. Each stemmed from a broken wire — called a lead — that tells a defibrillator when to send an electric shock to a malfunctioning heart. All six cases involved the Sprint Fidelis 6949, manufactured by Medtronic Inc., a leading ... Read More

A new concern for end-stage renal disease patients

Nephrogenic systemic fibrosis (NSF) is a new fibrotic skin disease entity that was first recognized in 1997 in 15 patients receiving hemodialysis. Early reports noted that NSF closely resembled scleromyxedema, but had a number of differentiating features. The entity was initially termed nephrogenic fibrosing dermopathy, and a case definition was established based on its characteristic clinical and histopathologic features. The name was later changed to NSF in view of the systemic nature of the disorder and recognition of the role circulating fibrocytes play in mediating NSF. Underlying renal impairment is a prerequisite for the diagnosis of NSF, and 90% of ... Read More