Re: FYI: Defective Medtronic Lead

[Guest guest]

Here is the link to the article. Try not to worry, it is only a particular lead that were implanted after 2001.http://www.nytimes.com/2007/10/15/business/15device.html?_r=1 & hp & oref=slogin

~guin

FYI: Defective Medtronic "Lead"

See "Patients Warned as Maker Halts Sale of Heart Implant Part" in cover story of today's New York Times.

[Guest guest]

Guin,

That is me. I don’t know what that means when the

ICD is replaced because of battery failure. My ICD was implanted on September 2005 so hopefully

Medtronics and my doctors will have a good plan by then. The failures are about 2.5% at 30

months. I am at 25 months. I can’t tell if you have made it past

30 months if your risk increases or stays the same. Actually I am listening to the conference call while writing

this and they really don’t know.

For some leads the long term risk improves with age but this is a wait

and see thing.

It appears that there are changes to

the settings that the doctor can make to lesson the risk and increase the

chances that you will be notified if there is a problem.

It appears that the doctors are just

now being informed of the recall. I

would think that waiting a few days before calling your doctor would be wise.

http://www.medtronic.com/fidelis/index.html

At the above site there is

information that may help understand the issue. There is also links to a conference call about the issue.

Let’s see if I need the ICD there is

a relatively small chance that it will fail. If I don’t have the ICD and have a VF event then there is a

very high chance I will not be writing anymore emails or doing anything for

that matter.

Needless to say the email got my

attention.

Life is interesting.

Joe Schmidt

God

Loves Us All

-----Original

Message-----

From:

[mailto: ]On Behalf Of Guin

Van Dyke

Sent: Monday, October 15, 2007

10:37 AM

Subject: Re: FYI:

Defective Medtronic " Lead "

Here is the link to the article. Try not to worry, it is

only a particular lead that were implanted after 2001.

http://www.nytimes.com/2007/10/15/business/15device.html?_r=1 & hp & oref=slogin

~guin

-----

Original Message -----

From: prelda

Sent: Monday, October 15,

2007 7:06 AM

Subject:

FYI: Defective Medtronic " Lead "

See " Patients Warned as Maker Halts Sale of Heart

Implant Part " in cover story of today's New

York Times.

[Guest guest]

Good luck Joe. I have been involved in a recall back in 2000 - just 5 mos after my first unit was implanted. I had to have it replaced, so thank God, I am not involved in this one. My leads were implanted in 1998.

Keep us posted.

~guin

FYI: Defective Medtronic "Lead"

See "Patients Warned as Maker Halts Sale of Heart Implant Part" in cover story of today's New York Times.

[Guest guest]

I got a new device and lead in 2005, both Medtronic -- the lead is on

the recall list. About 2 months after it was implanted I started

having problems -- oversensing of T waves and then a couple of hours of

inappropriate shocks (ouch). They repositioned the lead, and things

were better, but last summer it suddenly started oversensing T waves

again. I'm waiting to hear back from my EP docs -- I have a funny

feeling I might have a bad lead. If (when?) I get any additional

information, I'll post it.

As for whether this is officially a recall, I gather leads that haven't

been implanted yet have been recalled -- they aren't supposed to be

used. If the lead is already implanted, I gather it's an " advisory " ,

and needs to be discussed with one's doctor(s). Semantics...

Also, there was a suit filed this morning (Tuesday) against Medtronic

(big surpise).

I hope everybody's lead is OK. Take care, and stay well.

- Roxe

>

> See " Patients Warned as Maker Halts Sale of Heart Implant Part " in

cover story of today's New

> York Times.

>

[Guest guest]

Roxe,

Please explain "oversensing of T waves" I don't exactly understand. My device and lead were implanted in Jan 2006. My lead is on the list also.

Sydney

Re: FYI: Defective Medtronic "Lead"

I got a new device and lead in 2005, both Medtronic -- the lead is on the recall list. About 2 months after it was implanted I started having problems -- oversensing of T waves and then a couple of hours of inappropriate shocks (ouch). They repositioned the lead, and things were better, but last summer it suddenly started oversensing T waves again. I'm waiting to hear back from my EP docs -- I have a funny feeling I might have a bad lead. If (when?) I get any additional information, I'll post it.As for whether this is officially a recall, I gather leads that haven't been implanted yet have been recalled -- they aren't supposed to be used. If the lead is already implanted, I gather it's an "advisory", and needs to be discussed with one's doctor(s). Semantics...Also, there was a suit filed this morning (Tuesday) against Medtronic (big surpise).I hope everybody's lead is OK. Take care, and stay well.- Roxe>> See "Patients Warned as Maker Halts Sale of Heart Implant Part" in cover story of today's New > York Times.>

[Guest guest]

I just called medtronic as I have one of the faulty leads. They said letters about this went out to doctors in March 2007. Nothing was ever mentioned to me about this, anyone else heard anything from their doc before now?

Judi

Re: FYI: Defective Medtronic "Lead"

I got a new device and lead in 2005, both Medtronic -- the lead is on

the recall list. About 2 months after it was implanted I started

having problems -- oversensing of T waves and then a couple of hours of

inappropriate shocks (ouch). They repositioned the lead, and things

were better, but last summer it suddenly started oversensing T waves

again. I'm waiting to hear back from my EP docs -- I have a funny

feeling I might have a bad lead. If (when?) I get any additional

information, I'll post it.

As for whether this is officially a recall, I gather leads that haven't

been implanted yet have been recalled -- they aren't supposed to be

used. If the lead is already implanted, I gather it's an "advisory",

and needs to be discussed with one's doctor(s). Semantics...

Also, there was a suit filed this morning (Tuesday) against Medtronic

(big surpise).

I hope everybody's lead is OK. Take care, and stay well.

- Roxe

>

> See "Patients Warned as Maker Halts Sale of Heart Implant Part" in

cover story of today's New

> York Times.

>

Email and AIM finally together. You've gotta check out free AOL Mail!

[Guest guest]

Hi Sydney -

I'll give it a try -- this is one of those concepts I have a basic

understanding of, but not necessarily enough to explain, or explain

well... If anybody has a better explanation, jump right in! :-)

I think the short answer is that the lead & device are a little too

enthusiastic about sensing the heart rate, and wind up double

counting beats. That can result in inappropriate pacing or shocks

(not fun).

The long answer -- and I'm not sure how accurate this is: ECGs show

the heartbeat as a series of upward and downward spikes or bumps

(waves) - PQRST - indicating the heart's electrical activity. The R

wave is the big upward spike, followed by a smaller downward wave

(S), followed by a bit of a pause and then an upward wave (T). As I

understand it, if the ICD/lead is too sensitive, it mistakes the T

wave for a second beat instead of part of one PQRST, essentially

counting the heartrate as double what it really is. So if your real

heart rate is 95, the lead would be telling the ICD it's really twice

that (190), which of course isn't right. Then there's the potential

for an inappropriate therapy (pacing or shock) -- oops.

I gather this is a common problem with ICDs, and one they check for

during a device interrogation. The sensitivity can be adjusted by

programming the device. And that pretty well depletes my knowledge

on this one...

I hope that makes some sense...

- Roxe

> >

> > See " Patients Warned as Maker Halts Sale of Heart Implant Part "

in

> cover story of today's New

> > York Times.

> >

>

[Guest guest]

Thanks for the explaination Roxe,

Sydney

Re: FYI: Defective Medtronic "Lead"

Hi Sydney -I'll give it a try -- this is one of those concepts I have a basic understanding of, but not necessarily enough to explain, or explain well... If anybody has a better explanation, jump right in! :-)I think the short answer is that the lead & device are a little too enthusiastic about sensing the heart rate, and wind up double counting beats. That can result in inappropriate pacing or shocks (not fun).The long answer -- and I'm not sure how accurate this is: ECGs show the heartbeat as a series of upward and downward spikes or bumps (waves) - PQRST - indicating the heart's electrical activity. The R wave is the big upward spike, followed by a smaller downward wave (S), followed by a bit of a pause and then an upward wave (T). As I understand it, if the ICD/lead is too sensitive, it mistakes the T wave for a second beat instead of part of one PQRST, essentially counting the heartrate as double what it really is. So if your real heart rate is 95, the lead would be telling the ICD it's really twice that (190), which of course isn't right. Then there's the potential for an inappropriate therapy (pacing or shock) -- oops.I gather this is a common problem with ICDs, and one they check for during a device interrogation. The sensitivity can be adjusted by programming the device. And that pretty well depletes my knowledge on this one...I hope that makes some sense... - Roxe> >> > See "Patients Warned as Maker Halts Sale of Heart Implant Part" in > cover story of today's New > > York Times.> >>