Are they the same?

I know that an AED, an external defibrillator is the thing with th
paddles and the STAND CLEAR warning. But are these defibrillator
pacemakers?

Joel

PS~ Sue works in thsi field.

**

Posted on Wed, Aug. 17, 2005

M O R E   N E W S   F R O M    
• Medical Equipment
• Guidant
• FDA
• Medicine
• Healthcare Industry

Defibrillator cases generate questions

Consumer groups don't like how the FDA oversees recalls by companies o
medical devices and drugs.

By Rick Callahan

Associated Press

INDIANAPOLIS - Joyce Tierney and her daughter, Heidi, were rolled of
to surgery one morning two years ago just days after learning they ha
the same serious heart condition.

They emerged with implanted defibrillators that smoothed their errati
heartbeats with periodic jolts of electricity.

All was well until June, when Joyce Tierney, 47, received soberin
news: The mother of five from Montpelier, Ind., was among nearly
quarter-million Americans whose defibrillators have been recalled thi
year due to defects that could cause them to malfunction.

She said she began to wake up at night, "thinking it was a bad dream."

Since January, Indianapolis-based Guidant Corp. and the nation's tw
other primary defibrillator-makers - Medtronic Inc., of Fridley, Minn.
and St. Jude Medical Inc., of Little Canada, Minn. - have issued recall
or safety warnings affecting about 214,000 defibrillators.

The volume of recalls has raised questions about regulatory oversigh
and how companies alert doctors and patients about potential defects.

Consumer groups say the recalls highlight what they call the Food an
Drug Administration's cumbersome, hands-off process for handlin
recalls of medical devices and drugs.

Sidney Wolfe of the consumer watchdog group Public Citizen said th
FDA's recall process essentially relies on firms to tell the agenc
about potentially defective products.

"All too often, recalls are started late, are done dangerously slowly
and, even after they're done, they aren't as complete as they shoul
be," Wolfe said.

Guidant has acknowledged waiting three years before telling abou
24,000 patients and their doctors about an electrical-system defec
with its Ventak Prizm 2 DR Model 1861, which was recalled June 17 an
was linked to two patient deaths.

FDA spokeswoman Julie Zawisza said the agency rarely orders recalls
preferring to work with companies to assess the risks posed by
product. "It's a judgment call," she said.

That's little consolation to thousands of patients like Tierney, whos
Guidant implant was swapped with a new Guidant model during outpatien
surgery in June. Her daughter's defibrillator, also a Guidant model
was not one of those recalled.

Use of implanted defibrillators in the United States has grown fro
about 21,000 in 1995 to more than 250,000 this year, largely because o
advances in technology and surgical techniques, according to the Hear
Rhythm Society, a group of cardiac-care specialists based i
Washington.

Fred McCoy, president of Guidant's Cardiac Rhythm Management division
said the company's engineers have worked to ensure the safety an
quality of its products. The company said Aug. 1 that it had receive
FDA approval to relaunch its top-selling implantable defibrillator, th
Contak Renewal 3, which was recalled June 24 because of a faulty switch

--
Joel34