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.

In May of 2009 Medtronic sent out a "Dear Doctor" letter warning that specific subsets of Kappa and Sigma series pacemakers may fail at a higher than expected rate due to seperation of wires that connect the electronic circuit to other pacemaker components (e.g., batter, connector). The seperation of wires may present cause the device to have a loss of rate response, premature battery depletion, loss of telemetry, or no output.

Since 1997, there have been over 1.7 million Kappa and Sigma devices implanted worldwide. Combining the new subsets of Kappa and Sigma pacemakers subject to the advisory with the Sigma pacemakers from the 2005 advisory brings the total number of active devices now affected to 36,900 (~2% of all Kappa/Sigma devices implanted).

Patients, whose devices experience a wire separation resulting in a loss of pacing output, will experience a return of bradycardia symptoms (e.g. fainting or lightheadedness). In some cases involving pacemaker dependent patients, wire seperation will cause loss of pacing output may result in death or serious injury. Medtronic has received two reports of patient death where it is possible but unclear whether this issue may have been a factor.

New Medtronic Kappa and Medtronic Sigma Wire Seperation
Worldwide, an estimated 15,200 active Kappa devices and 6,100 active Sigma devices, manufactured primarily between November 2000 and November 2002, are affected by this issue. Most of these devices have been implanted in patients for five years or longer and may be nearing normal elective replacement time.

Medtronic has observed 285 Kappa devices and 131 Sigma devices with this failure mechanism from these new Medtronic Kappa and new Medtronic Sigma device subsets. This represents 0.49% (Kappa) and 0.88% (Sigma) of the original affected implant population. Current modeling predicts failure rates of 1.1% (Kappa) and 4.8% (Sigma) over the remaining lifetime of these Medtronic pacemakers due to Medtronic pacemaker wire seperation. There is no testing that can predict which specific Medtronic pacemakers may fail, and no device programming can mitigate this issue if it occurs.

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

• InSync l Marquis
• Insync ll Marquis
• InSync lll Marquis
• InSync Protect CRT-D
• Kappa 600/700/900 Series
• Marquis DR
• Marquis VR
• Maximo DR ICD's
• Meximo VR ICD's
• Sigma 100/200/300 Series

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.