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THE SIMPLE FACTSTM...Medtronic manufactures the Kappa 600 or 700 or 900 and Sigma 100 or 200 or 300 series pacemakers. On May 18, 2009, Medtronic issued letters to physicians warning them that there may be a problem with the electronic circuitry inside the devices (the wires that control the pacemaker).
The Kappa and Sigma pacemakers have been implanted worldwide since 1997. Recently, the FDA issued a Class 1 recall of the Medtronic Medtronic Kappa 600 or 700 or 900 and Sigma 100 or 200 or 300 series pacemakers.
On May 27, 2009, Medtronic issued letters to the patients that have these recalled Medtronic Kappa 600 or 700 or 900 and Sigma 100 or 200 or 300 series pacemakers (registered devices) to inform them of the recall and to advise them to seek medical help if they experience symptoms of lightheadedness or fainting (one sign that your pacemaker is not functioning properly).
Apparently, there may be a problem with Medtronic Kappa 600 or 700 or 900 and Sigma 100 or 200 or 300 series pacemakers due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.
The separation of wires may potentially lead to loss of rate response, premature battery depletion, loss of telemetry, or no output, potentially causing patient symptoms such as fainting and lightheadedness. The manufacturing dates for the Medtronic Kappa 600 or 700 or 900 and Sigma 100 or 200 or 300 series pacemakers range from November, 2000 through January, 2005.
If you have one of the recalled devices, please contact your physician immediately. If you experience fainting or lightheadedness, please seek immediate medical attention.
For more information on Medtronic's Kappa 600 or 700 or 900 and Sigma 100 or 200 or 300 series pacemakers, click here.
Quite frankly, the simple factsTMabout the problems associated with Medtronic’s Kappa and Sigma series pacemaker products are not acceptable.
We are here to help you protect your legal rights and the legal rights of your loved ones.
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