On February 10, 2005 Medtronic Inc. issued an alert to doctors regarding several models of implantable cardioverter defibrillators (ICD) and CRT-D devices with batteries manufactured prior to December 2003. The Medtronic warning was issued because the pacemakers are known to be plagued with defects which can lead to rapid battery depletion. The battery depletion is the result of an internal short. Once the defibrillators malfunction battery depletion may occur over the course of several days or in as little as several hours.

To date, Medtronic has found defects in several devices out of 87,000 inspected. Thousands of patients throughout the world rely on these pacemaker like devices. Nearly 75% of Medtronic's defibrillators are implanted in US patients and over 13,000 people have already had the device surgically removed. Medtronic has offered to replace the $20,000 device and pay several thousand dollars in additional expenses however they have not to date committed to pay for the necessary second surgery.

The defective implantable cardioverter defibrillators (ICD's) include the following models which were manufactured between April 2001 and December 2003:

• InSync I Marquis
• InSync II Marquis
• InSync III Marquis
• InSync III Protect CRT-D
• Marquis DR
• Marquis VR
• Maximo DR ICD's
• Maximo VR ICD's

In addition to the models listed above Medtronic also warned doctors wires could separate on an older model pacemaker called the Sigma series. Medtronic said it has spotted the wire problem in 19 devices, or 0.05 percent of that class of Sigma pacemakers. It estimated that perhaps 0.17 percent to 0.30 percent of the devices might develop the problem over the device's projected 10-year life.

Medtronic spokesman Rob Clark said problems in 14 of the 19 pacemakers were discovered because the device failed to work right, causing symptoms such as dizziness or fainting for some of those patients. No patient deaths or injuries have been associated with the problem, the Fridley-based medical device maker said.

The advisory to doctors covers about 28,000 pacemakers sold worldwide, including approximately 6,650 in the United States, the company said. The Sigma, which sells for about $4,000, is one of Medtronic's older pacemakers and is now mostly sold overseas, Clark said.

Medtronic told doctors that it is not recommending replacing the pacemakers ahead of schedule. It said the Food and Drug Administration may classify the problem as a recall.

Ennis & Ennis, P.A. is representing individuals that have have been effected as a result of defective Medtronic implantable cardioverter defibrillators (ICD's) or pacemakers. If you or a loved one have have had the device replaced or plan to have it replaced you may be entitled to compensation regardless if you suffered as a result of complications from surgery or the device itself. Click here to contact one of our Medtronic lawyers about a Medtronic lawsuit today.