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THE SIMPLE FACTSTM...Medtronic manufactures the Kappa 600/700/900 and Sigma 100/200/300 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).
FDA and Medtronic Action
The Kappa and Sigma pacemakers have been implanted worldwide since 1997. Recently, the FDA issued a Class 1 recall of the Medtronic Medtronic Kappa 600/700/900 and Sigma 100/200/300 series pacemakers.
On May 27, 2009, Medtronic issued letters to the patients that have these recalled Medtronic Kappa 600/700/900 and Sigma 100/200/300 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 600/700/900 and Sigma 100/200/300 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 600/700/900 and Sigma 100/200/300 series pacemakers range from November, 2000 through January, 2005.
On June 11, 2009, the FDA issued a Class 1 recall of the Medtronic Medtronic Kappa 600/700/900 and Sigma 100/200/300 series pacemakers. The Class 1 recall is the highest level recall issued by the FDA and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.
It appears that the recall may affect approximately 20,000 - 21,000 of the Kappa 600/700/900 and Sigma 100/200/300 series pacemakers. Patients can determine if their pacemaker is part of this recall by contacting Medtronic at 1-800-505-4636 or going to the firm's Web site.
It appears that Medtronic is advising physicians to do one of the following if the patient has an affected device: consider device replacement for patients who are both pacemaker dependent and who have been implanted with a device in the affected subsets; and continue routine follow-up in accordance with standard practice for those patients who are not pacemaker dependent.
If you have one of the recalled devices, please contact your physician immediately.
If you experience fainting or lightheadedness, please seek immediate medical attention.
Quite frankly, the simple factsTMabout the problems possibly 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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