Important Patient Information
Kappa® 600/700/900 Series of Pacemakers
Sigma® 100/200/300 Series of Pacemakers
May 2009
Dear Medtronic Kappa or Sigma Pacemaker Patient:
Medtronic is providing doctors with important information about a small and specific group of Kappa and Sigma series pacemakers. Approximately 2% of all Kappa and Sigma pacemakers are included in this group.
To determine if your pacemaker is included in this group, you can look at this on wwwp.medtronic.com/productperformance. You will need the serial number of your pacemaker, which is available on your Medtronic patient identification card. If your device is not in this group, this information doesn’t apply to your pacemaker and no action is required from you or your doctor.
If your device is in this group, we are providing this information to the doctor whom, according to our records, you see for your pacemaker check-ups.
Information for patients with affected pacemakers
In this group of pacemakers, Medtronic has found that there is a small chance that some Kappa and Sigma series pacemakers may experience a problem with the electronic circuitry inside the devices. Your pacemaker is most likely working properly. However, your pacemaker has been identified as one that may have a small chance of experiencing this problem. Your doctor can explain this potential problem in more detail to you, as we have provided him or her with additional information.
While the chances are small that your pacemaker will have an issue, every patient is different and your doctor is in the best position to advise you.
If you experience symptoms of lightheadedness or fainting, this may be one sign that your pacemaker is not functioning properly. If you experience these symptoms, seek medical attention immediately; do not wait for your next appointment.
We sincerely apologize for any difficulties this may cause you and your family. If you have additional questions, please contact Medtronic Patient Services at 800-551-5544
Sincerely,
Tim Samsel
Vice President, Quality and Regulatory
Medtronic Cardiac Rhythm Disease Management