Newspaper Clipping FYI

Was reading the newspaper today and came across this little article and just thought I would share it. Doesn't really relate to me, but thought some of you might be interested in it.

Medtronic shares drop 12%

Minneapolis - Medtronic Inc. is stopping distribution of wires that connect some of its defibrillators to patients' hearts after learning they may have contributed to five deaths.
Medtronic shares dropped more than 12% by midday Monday after the disclosure.
A defibrillator monitors a patient's heartbeat; if it senses an abnormal heart rhythm, it delivers an electronic shock to reset the heart to a normal beat. A defibrillation system consists of a device............
Medtronic said it discovered a "small chance of fractures in particular locations" on Sprint Fidelis models 6930, 6931, 6948 & 6949. The company is asking doctors to stop implanting the leads and return unused leads to Medtronic.
A fractured lead "can cause the defibrillator to deliver unnecessary shocks or not operate at all," said Daniel Schultz, director of the FDA Center for Devices and Radiological Health.

Not so much cheer,



What next

by shovelhead - 2007-10-18 10:10:46

I have the 6949 lead, lucky me! Got my 1st PM in 99, a Guidant. In Feb. 06 it was replaced, due to recall. In July 06, that Guidant PM was also recalled! Having a trust issue with Guidant, (they had announced an advisory on my 2nd PM in Sept. 05, 6 months before it was implanted. I did NOT want another Guidant product, after they knowingly implanted me with a suspect device! So I switched manufactures and got a Medtronic PM/Defib.
The PM clinic called me this week, and wants to do an additional call in on the 24th of Oct. Then I see my heart doc on the 31st, to discuss my options. The PM clinic wants to see me before the doctor's visit, to adjust the alarm perimeter.
This is pretty scary stuff! Will post again after I see the doc, to let everyone know what the real story is.

Me, too

by lindalouwho54 - 2007-10-19 10:10:52

I also have the Sprint Fidelis, 6949. I meet with my cardiologist on the 29th. Worrisome, but I do think I am safer with a defibrillator than without, even in light of the announcement.

me three

by rc - 2007-11-07 08:11:18

Also have the 6949 leads --
In a letter that I received from the "electrician" I'm suppose to attend a q&a at the hospital tomorrow evening -- reps from Medtronics will be there to answer specific questions etc. They're also suppose to do interrogations and determine the next step.
From what I understand, there are three options:
1. replacement -- which from what I have read, may not be the best option according to FDA. But not 100% sure if these reports are slanted or not.
2. disconnect and cap the existing leads, and then replace with a different model;
3. adjust the ICD to make it more sensitive to picking up on cracks in the leads.(somehow I would have thought that they SHOULD be at this setting!!!)

Anyway, I'll check back in after I see what all the gurus have to say.

You know you're wired when...

You have a little piece of high-tech in your chest.

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