More News on the Medtronic Lead Problem

This may be worse than initially reported:

http://online.wsj.com/article/SB123697437188922919.html?mod=googlenews_wsj

4 Comments

Medtronic Leads

by Bill-2 - 2009-03-13 11:03:44

From The Wall Street Journal
By THOMAS BURTON
Medtronic Inc. said the number of deaths in which its fractured defibrillator wires may have been a "possible or likely contributing factor" has risen to 13.

The wires, called "leads," went by the brand name Sprint Fidelis until they were pulled from the world market in October 2007. These leads are designed to carry electrical jolts to the heart and correct heartbeats that have gone haywire.

The new number, contained in a letter to doctors, is the company's first update of its death estimate since the Sprint Fidelis, then the No. 1 such device in the world, was first recalled. At that time, the Minneapolis-based company said the device could have contributed to five deaths. An estimated 268,000 Sprint Fidelis leads had been implanted in patients world-wide. The company and doctors say that when the leads fracture they either can fail to dispatch needed electrical therapy or can fire off multiple unnecessary shocks that themselves can result in death.

Four of the 13 deaths resulted from doctors' attempts at pulling out Sprint Fidelis leads -- highlighting the riskiness of such extraction surgery. The leads typically scar onto the inner vein wall or onto the heart itself. Either way, pulling it out can result in potentially lethal bleeding. For that reason, the company still doesn't recommend extraction in most cases.

The company said it has received 107 reports "that include allegations that the Fidelis lead may have caused or contributed to a patient death." Medtronic said an independent doctors panel has reviewed 89 of the reports, which were initiated by family members or lawyers "with minimal supporting data."

A federal judge in Minnesota threw out nearly 700 Sprint Fidelis lawsuits earlier this year. Judge Richard H. Kyle wrote that his ruling was forced by a U.S. Supreme Court opinion that holds that federal regulation of medical devices by the Food and Drug Administration "preempts" the possibility of liability cases under state law. Congress is expected to consider this issue in coming weeks.

Not Shocked

by MRSNO1MAX - 2009-03-16 11:03:06

I'm not surprised, It has hurt alot of people. The sad part is that the wires were not FDA approved they were piggybacked on their others leads that were approved. They knew there was a problem long before they released the information to the public. Hopefully Congress is going to do something about it now.

recalled wires

by huskersnb2 - 2009-05-12 11:05:13

hello
i had the pacemaker diefb that was on recall I had mine removed I got shocked 13 times 11 with in a minute and 2 more the next day at hospital i know what these people are going through becuase it happened to me and it no fun and max how do you know these were not fda approved if you have an y info on this email me so i can pass it on to my lawyer and i hope congress does help us out duane

update on congress decision????

by sunnyak - 2010-05-23 02:05:30

Any updates?

You know you're wired when...

You read consumer reports before upgrading to a new model.

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