Thursday, September 10, 2009

A New Medtronic Defibrillator Advisory Issued Today

Today, an announcement was issued to doctors implanting Medtronic's Concerto and Virtuoso wireless implantable cardiac defibrillator's (ICDs) that a certain lot of 5,200 devices in the US of the total 158,000 implanted worldwide have demonstrated premature battery depletion due to a faulty battery capacitor containing porous copper. A total of 230 devices returned so far have demonstrated this problem. The capacitor was manufactured by an outside vendor, and more recent models of these devices manufactured reportedly no longer have this capacitor.

The notification is not a recall and does suggest any of the devices have failed and no deaths have been reported as a result of this notification. It is recommended that physicians continue the routine follow-up of these devices every three months and the patient alert feature be programmed "ON-High" for the Low Voltage Battery alert.

You can look up specific serial numbers of Concerto biventricular defibrillators(Model C154DWK) or Virtuoso DDDR defibrillators (Model D154AWG) models that might be affected at http://CVSNList.medtronic.com.

-Wes

2 comments:

Helen said...

I just looked up my Virtuoso serial number, and it looks like it's fine. It's great to be able to just type it in and find out for yourself.

Thanks for posting this.

Hugo Campos said...

I have looked up my serial number as well and I am not affected. Thanks for the post, Dr. Wes. With your permission, I'll pass the information along to the ICD patients in my group!

Thanks!