Certain Medtronic Pacemakers have been known to have defects that may lead to rapid battery depletion. If you or a loved one have had the device replaced or plan to have it replaced you may be entitled to compensation.

Medtronic Pacemaker Recall
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 that wires could separate on an older model pacemaker called the Sigma series. Medtronic said it had spotted the wire problem in 19 devices, or 0.05 percent of that class of Sigma pacemakers. It is estimated that perhaps 0.17 percent to 0.30 percent of the devices might develop this problem over the devices projected 10-year life.

Have the defected models been replaced?

To date, Medtronic has found defects in several devices out of 87,000 inspected. Millions 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.

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If you or a loved one have been injured as a result of Medtronic pacemaker wire seperation, Medtronic defective battery, or 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. Contact the Medtronic attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and Medtronic lawyers are standing by to answer any questions you may have regarding the Medtronic pacemaker defects, a possible Medtronic class action lawsuit, or any other type of Medtronic Pacemaker litigation.

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