FDA versus Heart Patients w/Pacemakers (johnwen?)

[ofonorow]

Not long ago, I said I was advising a 65 year old man with a pacemaker who had a fluid buildup around his heart. The hospitalization successfully drained the fluid and he feels/felt much better. During this episode, he learned that his pacemaker had "noticed" the problem and set an alarm, but the patient was not notified.

He asked his doctor why he wasn't notified, and was told that the FDA prohibits it.

Why he asked, "Why?" The doctor said he had no idea.

Johnwen, is this true? (If so, it clearly illustrates what is wrong with a governmental oversight function.) Unless this is simply false information, it means that because the company has not 'satisfied' the FDA that its reports are accurate, i.e., the FDA has not approved the use of pacemakers for this purpose.

Make any sense? He went on a trip, thinks there may be a fluid build-up again, but has to go through hoops to initiate a request. This is just nuts.

[Johnwen]

It's really kind of hard to say without knowing the manufacturer and model of his pacemaker.
In most of the medtronic's the alarm means the battery is getting low, Some have a audible alarm that goes off everyday at a set time as a test function. Others have a table top receiver that has an alarm to wake you up or caretaker to notify of problems. It also calls a monitor center who gets a hold of the doctor with the information. Some you push a button and sends the info to the doctors office. Some you walk into the doctors office and before you sit down they already got a reading on you. It changes everyday something new comes out!
As far as not notifing the patient of a problem during a monitoring session is wrong!
If the doctor sees a problem with a tramsmission from a monitor pacemaker he is obligated to inform the patient what action the patient needs to take. Ie Go to Hospital, See me tommorow, Call 911 etc. If he has a unapproved pacemaker he needs to get it out of him.
This technology is designed to save lives by providing info to the patient and the doctor so corrective action can be taken, before it gets out of hand. Restricting info to the patient is not a option.

[ofonorow]

Here is what he says about his pacemaker:

it is called a virtuoso dr defibrillator combo pace/defib. Has the defective lead and the water alarm is turned off per my dr because the fda says it cant be turned on. Maybe it is a freq thing?
i dont know but when he calls i will ask again

[Johnwen]

I'm thinking his Dr. only hooked it up with 2 leads instead of 3. Usually because of insurance restrictions. If his QRS (EKG) wasn't showning a need for the 3rd lead the insurance co. only pays for a 2 lead hook up. Some of these were recalled in 2009 because of various problems from battery to chips malfunctioning. The link here will take him/you to the latest info all you do is enter the serial number and it gives you any problems they have found on that particular model.



http://wwwp.medtronic.com/ProductLookup ... view=false

[ofonorow]

Thanks. The issue still seems to be the "water" alarm - which is reported to someone, somehow, somewhere, but is not reported back to him - the patient. (When in the hospital, he was told that his device had detected the excess water, (back in May - months earlier) but when he asked why no one told him, he was told because the "FDA doesn't allow it.")

[Johnwen]

Owen:
Seriously, this don't pass the smell test at all. I would ask the Hospitial/Doctor to see the regulations that the FDA supposely issued, that they are hiding behind and explain to him how it affects him and his device and what can be done to get something in him that is more reliable.
If they can't give him an acceptable answer then a trip to the hospitials adminstrator office would be the next step. If they can't provide a good answer or give him a copy of the FDA rules then the next step would be (COUGH,COUGH, CHOKE Gasp!) A LAWYER!!! There I said it!!
Might just be a little cover up of someone not doing their job. Which is spelled malpractice.


If they hand him a copy of this he's in trouble with a capital "T"

http://www2.nationalreview.com/dest/201 ... echart.pdf

[ofonorow]

I am a little worried about upsetting him. That chart is enough to make you cry! I've got to find a way to post it...
http://www2.nationalreview.com/dest/201 ... echart.pdf

[ofonorow]

http://www.totalrecallinfo.com/freerecalls.php?id=13521

Looking up this kind of defib/pacemaker, and found the above recall notice. (Asking him to check the model number) but how could there only be 2 in circulation, and they have that kind of data??

And apparently the leads can be THE problem (and have been recalled?!)
http://www.inspire.com/groups/care-cardiac-arrhythmias/discussion/icd-medtronic-defibrillator-lead-recall/


Here is a more complete list of recalls. http://forums.startsampling.com/showthread.php?t=38153

[Johnwen]

This could be the reason their giving him the run around it's possible his ICD is on a recall list and they are trying to figure out what they need to do. Right now theres no clear cut procedure on the recall of one of these devices and there is a group of doctors pushing the FDA for guidelines for problematic devices. Wait FDA setting guidelines for something that would cost a manufacture or doctor money to accomplish at NO COST TO THE PATIENT?????
ODDS= Slim to NONE

I know your a computer very knowledgeable person here's something that will give you a little more knowledge of these amazing micro devices. When you get a chance give it a read.
It'll get your attention just reading the link name

http://www.scribd.com/doc/20950196/PaceMaker-HAcking

[ofonorow]

Oh boy he gave me his model(s) and D154AWG is on the recall list?!? What now? Attorney?

virtuoso dr defibrillator
serial model
pul415978h d154awg
lfj205023v 694965id
bbl143210v 407652
i assume 3 models refers to lead pacemaker defib

from http://forums.startsampling.com/showthread.php?t=38153

3) Medtronic Virtuoso DR, D154AWG, Dual Chamber implantable cardioverter defibri
llator with atrial and ventricular therapies. This device is indicated to provid
e ventricular antitachycardia pacing and ventricular defibrillation for automate
d treatment of life-threatening ventricular arrhythmias in patients with NYHA fu
nctional Class II/III heart failure. In addition, the device is indicated for us
e in the above patients with atrial tachyarrhythmias, or those patients who are
at significant risk of developing atrial tachyarrhythmias. Recall # Z-0128-2010;

[Johnwen]

He should print out the information and have a good talk with his doc about what he found out about his ICD and how this applies to his situation. The docs actions and reactions will be a good indicator to him about what he should do. It's possible that a particular problem with his device might not have any bearing on his condition and is not a factor. Then on the other hand such as the ones that had bad solder connections which could cause complete shut down of the device when it's needed, his options are limited to complete replacement. As far as the water issue it would appear as a prolongated ,depressed or elevated ST segment on the ekg read which alot of times are overlooked by inexperienced techs usually if there only mild changes such as with mild build up of fluid. But like in his situation where fluid build up is the concern this would be of great concern and they might just want to brush it aside and and chalk it up to learning. Their attitude might be is, "He made it thru it NO Biggy!! We'll catch it next time." Or it's possible his ICD didn't read it.
As you can see theres alot of if's and could be's and to me this not acceptable and a good push to get it replaced with a dependable, accurate device should be the route he pushs for!!

[ofonorow]

Full circle! The patient called Medtronics and was told that the recall had been rescinded, and gave him the same story the doctor had given him. The water alarm is not approved by the FDA. He was told that the FDA was too busy, too few people, and had not approved the water alarm. So rather than work under some type of conditional waiver until the alarm is "approved" it is apparently FDA policy to block use until approval. Too bad for the patient, but good for population control I suppose. (He plans to call the FDA today.)