Medtronic, the manufacturer of your defibrillator lead, has informed us of a potential issue with a specific lead. There have been rare incidents of lead fractures that could result in the inability to deliver appropriate therapy. At this time, the chance of this problem occurring is remote, however we want all of our patients to be informed of the issue and the potential risks. Most leads have a risk of failure of approximately 1-2%, while this particular lead's risk is between 2-3%. The predicted risk of failure may rise over the lifetime of these leads.
We are going to follow you device and lead information closely. The home monitoring system, called Carelink, enables us to view your information without you coming to the office. If you are not enrolled in this system, we will be glad to explain it in further detail and enroll you to receive the monitor. Another precaution we are taking is to reprogram the alert notification system in your device. Your defibrillator has an alert system which alarms if the lead measurement falls outside of a certain range. We will reprogram that range to notify a detected change sooner. We will be scheduling your next appointment to be in the clinic to make the changes. Then we will start following your device every 3 months by way of Carelink or a clinic visit.
We regret any concern that this may cause you. We remain committed to providing you the best care and will work with you to minimize any inconvenience. |