A Joint Programme with the Peterborough Regional Health Centre

Oct. 16, 2007

Re: IMPORTANT NOTICE REGARDING YOUR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEAD

Dear : ________________________________

I am writing to inform you of a recent concern about your ICD (Implanted Cardiac Defibrillator) that has been reported to us by Medtronic. Medtronic is the manufacturer of the lead or “wire” that connects your ICD to your heart muscle.

Nature of the concern:

There appears to be a small risk (1 in 50 in the first 2 years) that your lead could fracture or break. This could cause an inappropriate shock, inability to deliver shock if needed, loss of pacing output, and, in extremely rare cases, death. [Only 5 deaths have been reported world-wide. While this is a concern, it is a very small number compared to the 268,000 leads implanted. Please try to keep this in perspective.] For the vast majority of patients the lead may not be a problem.

Currently, it is our belief that the risks and complications associated with the removal and/or replacement of normally functioning leads would be higher than the risks posed by simply continuing to follow your lead’s performance in the clinic. Of course, if we do detect any signs of lead failure or malfunction we will take immediate corrective action to ensure you are provided with all of the capabilities that your device has to offer.

Our plan:

We are monitoring the situation very closely on your behalf.
We are consulting with Medtronic, the Canadian Heart Rhythm Society, and the centre where you were implanted to develop recommendations for our patients.
We may be changing your regular follow-up schedule.
We may need to make some programming changes to your device in order to enhance the device’s ability to automatically detect a lead problem.

Staff from our Cardiac Rhythm Device Clinic will be contacting you in the near future to arrange a clinic visit, perform a thorough evaluation of your device and lead, discuss your ICD lead situation and to develop a plan that is right for you.

Our commitment to you:

We want to reassure you that we are committed to the highest standards of care for you, and for all of our patients. We are confident that the risk posed to you as a result of this particular ICD lead is extremely low and we will continue to monitor this situation closely.

Please feel free to contact the Peterborough Regional Pacemaker Clinic 705.740.6888 ext. 230. You can also keep up with any changes in the recommendations for this problem by checking our website at: www.kawarthacardiology.com.

Sincerely,

William G. Hughes, MD, FRCPC

Cardiologist

Medical Director, Peterborough Regional Pacemaker Clinic