Patient registry at valve manufacturers

[Johan]

I am now about 6 month's post op and approached my surgeon's PA to get the exact model and serial/registration number of my new aortic pericadium valve (CE). She thumbed through my file but had no information available and was rather off-hand with me.

She referred me to the dispensing pharmacy in the hospital. They could not help me either, just made a joke to the effect " we can always cut you open and hopefully the number will be printed on it" and "do you want the box it came in?" Yes I very much want the box and the serial number and the exact make and model and a 25 year warranty. This lack of information gets my suspicious mind going....did I get a second hand valve, a reject, a local blacksmith's tinkering??

Seriously, do the manufacturers keep a record of each of their valves and the patient it went to. Do any of you know, or better do you have certificates indicating that you are the proud owner of such and such a valve and that it is registered in your name on some central data base?? Please help.

 

[sue943]

I was given a card for each of my ATS valves with details of the size and model plus a serial number.

It was my understanding that the valve manufacturers do keep records of who has which valve.

 

[ottagal]

Johan,
I received a wallet size card from Edwards about a week ago (and I am 7 weeks post-op).
It states name of hospital, surgeon's name, date of implantation, serial #, model and position.

I presume my surgeon registered me
I hope this helps.

The back of the card has a telephone number outside USA to call: 949 250-2500. This is for more information, technical support and it is the Edwards Lifesciences Patient Registry.
Good luck.

 

[Bina]

The St. Jude valves are registered and a wallet card was sent to me after surgery,
indicating serial number, contact phone numbers, etc.
I don't know what the procedure is in your situation....try to get the "extended warranty" if possible.

 

[Duffey]

I received my Edwards card about a month after my surgery.
I just looked at my card and here's the address in case you want it.

Implant Patient Registry
PO box 11150
Santa Ana, CA 92711-1150
USA

Tel: 1 949 250 2500

www.edwards.com

 

[kfay]

Check your discharge papers from the hospital. I was given a packet that I assume came with my valve that had stickers with the serial number on it and a temporary ID card when I left the hospital. I then went onto the St. Jude's website to register it when I got home. They then mailed me a card in a couple of weeks. I doubt the valve company will have your info unless you or someone else registered it for you.


Kim

 

[Johan]

Thank you Sue, Ottowagal, Bina & Duffey for your prompt responses and the Edwards Life Sciences contact details.

It would seem as if my surgeon's office never registered my valve. Strange. I shall now contact Edwards directly and get the ball rolling. Thanks again for your help.Registration and wallet cards to go with it, seems to be the norm and I can now confidently approach both Edwards and my surgeon's PA.

Bina, I will let you know if I managed to get an "extended warranty" out of them as compensation and a good customer relations exercise, for not registering me in the first place.

 

[Johan]

Thanks Kim. Just checked all my discharge papers but nothing there. Somebody slipped up badly. Partially my fault I suppose, should have been more alert to this sort of thing. I just took it for granted that all the info would be on my file with the surgeon....

 

[dick0236]

Seriously, do the manufacturers keep a record of each of their valves and the patient it went to. Do any of you know, or better do you have certificates indicating that you are the proud owner of such and such a valve and that it is registered in your name on some central data base?? Please help.

I know that Edwards Lifesciences, whom I believe may be the manufacturer of your valve keeps valve records. They also manufactured my valve, and after my long scramble for old information, they produced a card for me. Your surgeon or hospital must have enough of a record that will allow you to have Edwards prepare an ID card and include you in their system. It is in your best interest to get and keep this card. A few years ago, I was denied an MRI because I had no card and the hospital involved could not verify that my valve was MRI safe. Unfortunately, all my medical records held by my cardiologist and Edwards Lifesciences had been lost. Fortunately, the hospital still had a sketchy record that proved the implementaion of a mechanical Starr-Edwards valve. I now have an ID card from Edwards that states I have their valve "model unknown-StarrEW" with the serial number "UNK-178". Nobody knows exactly what I have, although we can make a good guess since few valves were available at that time. With the variey of valves now being used, I would want a good record of what I had......just in case.

 

[Ross]

It may depend on what the country laws are as to whether or not they must be registered.

 

[ALCapshaw2]

Sounds like rather SLOPPY Record Keeping by your Surgeon AND Hospital!

You may want to send a letter to each documenting the Lack of proper Record Keeping on their part.

Do you have a Better Business Bureau?
I *assume* there is some official agency that licenses the hospital and surgeons.

If so, you could send copies of your letter to them.

 

[Mentu]

Johan, your surgeon's office should have registered your valve with Edwards following your surgery or as in my case, provided you with the information so that you could register your valve. Edwards then issues you a card just as the others described. I think this is standard procedure for all such implants because it allows the manufacturers to perform follow-up studies. Also, in the event that a group of implants is found to be faulty, it makes it possible to contact those individuals who received them. You might want to start by speaking with someone else in your surgeon's office. My own surgeon has a technical assistant whose primary job is to prepare the implants during surgery. Another place to check would be your insurance company. Someone has the serial number of your valve.

When you contact Edwards to register it, they will ask for the information Ottwawgal listed. Since you are outside of North America, the contact number is 00-1-949-250-2500 as Duffey gave you. By the way, if you have not used Skype for overseas calls, I can recommend it. When I was in China it was only $0.02 a minute to use Skype while our commercial telephone service wanted $2.50 a minute.

 

[Johan]

I am not sure about our laws regarding registration of this sort of thing, Ross, but as Al said at least some sort of record should have been kept by the surgeon or hospital, even if they are not compelled by law to register it as such. We do have a regulatory agency for private health care.

Must admit my nose is now out of joint over this whole thing and I shall follow up on Dick's experience and get enough information to allow Edwards Lifesciences to issue me with a card. If that fails, I shall approach the regulators.

The information in my signature, I gleaned from the cardio during a chat some time ago. He "thought" those were the specs for my valve but wasn't sure. He then suggested I verify with surgeon's office...

 

[Johan]

Mentu, I am so upset about the whole business, especially the dismissive and flippant responses I received from the ones who were suppose to be the custodians of this rather important patient information (to my mind anyway, being the patient involved), I have a good mind to e-mail the surgeon personally now, albeit already late on Friday night...

My wife just reminded me that during one of the surgeon's early visits to me in ICU he mentioned in passing that the Edwards Lifesciences representative in Cape Town was in the OR during my operation as an observer. On Monday I shall make work of a number of leads. Yes I am familiar with Skype, use it to talk to a family member in London, UK. Thank you everybody for your input. Shall keep you posted.

 

[Lionheart]

Johan,
It may help your case to know that we have the same valve, except mine's bigger, and my card from Edwards shows the following information

Front of card:

My Name
"Implant date" day-month-year
Surgeon's name
Hospital and address

Model-2700
Size- 27mm
Position- Aortic

Serial - 1234567
"Bovine pericardial Heart Valve"

On the back:

"This card contains information that may be helpful
to medical personnel when you seek care. Keep
this card with you at all times."

"For more information, technical supprt or to tell
your personal story, please contact Edwards
Lifesciences Patient Registry at:

www.lifeisnow.com
Tel (USA) 800.424.3278
Tel (outside USA) 949.250.2500
For MRI information contact us at www.edwardsmri.com"​

Give em hell.
John

 

[Bina]

Johan, don't be upset. Most patients never even realize that a card or serial number should be standard issuance. It will all get sorted out, take a deep breath and make a cup of tea.

 

[Jkm7]

I did not get any info re: my valve either. About 2 months post op, it occured to me I did not have this info and I wanted it. I called surgeon's office and they gave me contact info at Edwards. I e-mailed and named hospital, surgeon's name, date, my name and address and they found exactly the valve that was implanted and they forwarded me a wallet card. They were top notch excellent to deal with. Could not have been more responsive, efficient and helpful.

 

[terryj]

My husband got a card with ATS valve size and serial number and each year we get a letter from them letting us know there are no recalls on his valve and to see how he is doing. Makes you feel good about ATS

 

[Johan]

John, wow a 27mm valve! It was probably specially produced for a LIONHEART I suppose even in heart issues, size does matter, and there I am with a puny 21mm! . Thanks a lot for the detailed info.

Jkm7, I have already dashed off an e-mail to Edwards with all my surgery info etc. Thanks for the tip.

And Bina I am now enjoying a cup of cocoa, it always helps to lower my BP and HR and of course to get my nose back into joint!...

Sue that is why my nose was so out of joint in the first place.. one expects a bit of TLC from those in the dishing out department towards us at the receiving end..

 

[Bina]

Well, my "puny" 21mm has got tons of power and that is why I take Metoprolol to calm down the wild pumping.