URGENT - RECALL... implanted in 1997-1998

[Reenie]

Re: URGENT - RECALL... implanted in 1997-1998

Lisa, what a story! Sounds like someone was looking out for you!

Reenie

[Lisa Salberg]

Re: URGENT - RECALL... implanted in 1997-1998

Jerry -
Keeping up to date on these matters in very important. We try our best here, your doctors try their best and each of us individually keeps our eyes and ears open.
Back in 1997 I had one of the 1st DDD pacer/Defib units by Guident - One day I got to work and on my desk was a news clipping saying that "some were recalled" - this was a programing recall. Later that day (as fate would have it) I took my niece to the cardiologist - I ran into my EP in the hallway. He smiled and said hello. I said (thinking I was joking) - "so am I recalled to the mother ship or what?" His face got VERY serious and he said " oh my .... Uhmmm come with me" Off I went to the EP dept for my "reprograming". All because a guy who worked in the warehouse saw an article in the paper.

Best to all!
Lisa

[Jerry Salzman]

Re: URGENT - RECALL... implanted in 1997-1998

Hi all,

I have a GEM DR 7271, but mine is not under the recall. My doctor scheduled me for a replacement this week then called and said there was not a recall. After seeing this message I just called Medtronic. They said only older versions of the model were recalled.

It does make you wonder though!

Jerry

[Reenie]

Re: URGENT - RECALL... implanted in 1997-1998

Rich, it looks like the recall was issued on April 16th, so your doctor may not have known about it at your appointment. Let us know what they say.

Reenie

[Rich Miller]

Re: URGENT - RECALL... implanted in 1997-1998

Yea ,This gets my attention ,I have a Gem DR 7271 .Just had it interogated this week and no one said a thing!! I wonder if they didnt know or its the "old hush"routine? I guess I will call them on Monday and find out. Rich

[Lisa Salberg]

Re: URGENT - RECALL... implanted in 1997-1998

The procedure will vary from recall to recall- - in some cases the manufacture will pick up some of the costs, some time all of the costs. In this case these devices are at the "end" of the normal life span of a device, therefore I would think that the device company will pay a portion for replacements.

I am concerned about this recall due to the timing of the implants - HCM'ers had a big number of ICD implants begining in 1997-8 so I am sure that some of "us" are in need of attention.

Best wishes,
Lisa

[Linda]

Re: URGENT - RECALL... implanted in 1997-1998

Jim, in our experience, the device company covered expenses not covered by the insurance company. Ours was not a recall, but an individual device problem. When you have the device implanted, you are handed a set of warranty papers that explains it, just like buying a refrigerator. Linda

[mtlieb]

Re: URGENT - RECALL... implanted in 1997-1998

I'm just curious... how do you 'recall' an ICD? Does Medtronic foot the bill for the surgical procedure to have the device removed and replaced?

[Lisa Salberg]

If your device is a Medtronic and was implanted in 1997 and 1998 PLEASE check with your doctor to see if you are included in this recall.


Medtronic Announces a Nationwide, Voluntarily Recall of Small Subset of Two Implantable Cardioverter-Defibrillator Models


MINNEAPOLIS, April 16, 2004 – Medtronic, Inc. today announced that it is voluntarily recalling two older models of implantable cardioverter-defibrillators (ICDs). The Class I recall involves a small subset of Micro Jewel® II Model 7223Cx and GEM® DR Model 7271 ICDs that may take a longer than normal time to charge before delivering therapy. Most of these devices, implanted in 1997 and 1998, are close to the normal replacement time. No other Medtronic devices are involved in this action.
The Micro Jewel II device is no longer sold, and the GEM DR device has limited distribution. Physicians are being notified that they should verify the charge time and battery voltage of each affected device. If any devices exhibit unsatisfactory charge times, Medtronic recommends scheduling ICD replacement. The final decision whether to replace the device is based on the physician’s medical judgment and specific patient needs.

Implantable cardioverter-defibrillators are medical devices used to shock the heart into normal rhythm after patients suffer ventricular tachycardia or fibrillation, which are rapid, life-threatening arrhythmias originating in the lower chambers of the heart. The devices are surgically implanted in the chest in a minor procedure lasting less than one hour.

When a cardiac arrhythmia requiring cardioversion or defibrillation shock occurs, the capacitor is normally charged, and the device delivers the appropriate shock. With the cardioverter-defibrillators in this recall, the capacitors may take longer than normal to charge near the end of the battery service life and could cause a delay in delivery or a non-delivery of shock therapy. Such a delay or non-delivery could result in patient injury or death because patients are not receiving the appropriate therapy in time. Medtronic no longer uses this capacitor technology.

Recently, Medtronic became aware of one serious injury and four deaths that may be related to the failure of the capacitor in a small subset of Micro Jewel II devices.

A total of 6,268 of the affected ICDs were manufactured, of which about 1,800 are thought to be still implanted in patients worldwide. Medtronic is working with the U.S. Food and Drug Administration (FDA) to ensure that all physicians and their patients with these devices are notified of the issue. Medtronic began notifying physicians on April 5.

The FDA defines a Class I recall as a situation in which there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.

Medtronic, Inc., headquartered in Minneapolis, is the world’s leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is www.medtronic.com.

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