Physician Letter

Physician Letter (PDF)

Device Identification

Patient Letter

Patient Letter (PDF)

Important Patient Information

Medtronic InSync® III Cardiac Resynchronization Therapy (CRT) -Pacemaker
Models 8042, 8042B, 8042U

 

November 2015

Dear Medtronic InSync® III CRT- pacemaker patient:

Medtronic recently provided your doctor with important information related to implantable InSync III CRT-pacemaker Models 8042, 8042B and 8042U. Your pacemaker is most likely working properly; however, Medtronic has found that there is a very small chance that some InSync III CRT- pacemakers may experience an issue with the battery inside the device.

If Model 8042, 8042B, or 8042U is listed on your Patient Identification Card, then your pacemaker is an InSync III CRT-pacemaker. Another way to determine if your pacemaker is an InSync III CRT-pacemaker is to visit the Medtronic website at http://wwwp.medtronic.com/productperformance/ and enter the device serial number found on your Patient Identification Card to obtain information specific to your device.

If you determine your pacemaker is a model 8042, 8042B, or 8042U, your doctor can explain the issue to you in more detail with the additional information he or she has received.

If your pacemaker is not listed as Model 8042, 8042B, or 8042U, then this information doesn't apply to your pacemaker and no action is required.

What should I do if I have an implanted InSync III CRT-pacemaker, Model 8042, 8042B, or 8042U pacing device?

While the chances are very small that your pacemaker will have a performance issue, every person is different and your doctor is the best person to advise you on next steps.

Symptoms of lightheadedness or fainting can be a sign that your pacemaker is not functioning properly. If you experience these or any new or unexpected symptoms, seek medical attention immediately; do not wait for your next appointment.

What if I have questions?

Medtronic recommends that you contact your doctor for any questions or concerns relating to your heart device. For questions relating to this letter, you may also contact Medtronic Patient Services at (800) 551-5544, option 3, extension 41835, or via email at pshelp@medtronic.com. Patient Services is available to take your call Monday through Friday from 8 a.m. to 5 p.m. Central Time.

We sincerely apologize for any difficulties this may cause you and your family.

Sincerely,

Tim Samsel

Vice President, Quality and Regulatory

Medtronic Cardiac Rhythm and Heart Failure