Recently, Medtronic, Inc. released an advisory removing certain defibrillator leads from the market place. Many of our patients have devices with this lead in place. If you do not have a Medtronic device, this does NOT affect you. This is an advisory and does not require emergency treatment. In some cases, a programming change is recommended to allow closer monitoring of this particular lead.

Here are some facts about this lead problemprovided to us from Medtronic:    

1. There is NOTHING wrong with your ICD (the “box” under your skin). This advisory has nothing to do with the actual ICD model that you have in place.
2. Surgery to remove and replace this lead is NOT recommended.
3. Increasing the frequency of ICD checks either in the office or over the telephone is NOT recommended.
4. We will continue routine followup of your device. For most patients, the lead will be monitored over the telephone (Carelink) as usual.
5. You might be asked to come to the office to change some of the monitoring parameters in the computer software in your ICD.  Our office will contact you with an appointment.  You do not need to contact our office.

This information is also located at www.Medtronic.com. Click on the icon at the bottom of the page entitled: Important information about the Sprint Fidelis Defibrillator Lead.

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As you may already be aware, Guidant, Inc, has issued an alert regarding the performance of some of their ICDs. The devices affected include...

Prizm 2 DR (model number 1861) manufactured before April 16, 2002
Contak Renewal (model number H135)
Contak Renewal 2 (model number H155). manufactured before August 26, 2004
Contak Renewal 3 (models H170, H173, H175, H177 and H179)
Contak Renewal 3 AVT (model numbers M150, M155, M157 and M159)
Ventak Prizm AVT (model number 1900)
Vitality AVT (model numbers A135 and A155)

The model number of your device is noted on your identification card.

If you are not sure if your device is affected, then click here. This page will allow you to look up your particular device.

For more information, visit Guidant's site regarding this recall.

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Remember, ICDs are very safe devices. Malfunctions and failures are very rare. The ICD device, even if it fails to work properly, generally does not harm the person. Not all ICDs that have been the subject of an FDA recall need to be replaced. Some devices may require simple reprogramming. Check with us to determine what type of follow up may be needed. The small risks associated with replacing the device may still be much higher than the risk your device will malfunction. We will be happy to discuss the pros and cons of ICD replacement. Remember, every patient with an ICD should have regular follow-up with us. This follow-up includes office visits, and telephone-based remote monitoring.

If you have any questions, please call us at (860) 714-7977. We would be happy to discuss this with you.