Important Medical Device Information
September 2009
Dear Medtronic Concerto or Virtuoso Patient:
Medtronic is providing doctors with important information about a small and specific group of Concerto and Virtuoso devices.
To determine if your device is included in this group, you can look at this on http://CVSNList.medtronic.com. You will need the serial number of your device, which is available on your Medtronic patient identification card. If your device is not in this group, this information doesn’t apply to your device and no action is required from you or your doctor.
If your device is in this group, we are providing this information to the physician who implanted your device and the physician you see for your ongoing follow-up care.
Information for patients with affected devices.
Medtronic recently learned that some batches of batteries in Concerto and Virtuoso devices may not last as long as normally expected. We have determined that you have received either a Concerto or Virtuoso device that came from one of the manufacturing batches in question. The problem does not cause any immediate risks to you in any way and you remain protected by your device. You don't have to do anything different; just be sure to keep up with your regular device check-ups and doctor's appointments. All implantable devices like yours are battery operated and all battery-operated devices eventually require replacement. These are very sophisticated devices that have been designed to alert patients when the device is ready to be replaced. If you do receive an alert or a tone that you can hear coming from your device, contact your doctor – don’t wait for your next appointment.
If your device requires replacement during the warranty period, we will honor the device warranty. We also have programs to cover reasonable unreimbursed medical expenses – the part your insurance company or Medicare doesn’t pay.
Your doctor can answer any questions you may have, as we have notified both the physician who implanted your device and the physician you see for your ongoing follow-up care. You can also call the Medtronic Patient Services number at 800-551-5544 ext. 41835 if you have any additional questions. We sincerely apologize for any difficulties this may cause you and your family.
Sincerely,
Tim Samsel
Vice President, Quality and Regulatory
Medtronic Cardiac Rhythm Disease Management
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