Heart News
October 16, 2007
Cleveland Clinic Response to Medtronic's Voluntary Market Suspension of Their Sprint Fidelis Defibrillator Leads:
A message for our patients
Our team of physicians and nurses in the Implantable Device Clinic in the Cleveland Clinic Department of Cardiovascular Medicine is committed to patient safety. Today, Medtronic voluntarily suspended sales of their Sprint Fidelis Defibrillator Leads. At Cleveland Clinic, if the patient has enrolled in our remote monitoring program, we are able to monitor their device very carefully. If there is an issue, we are then better able to notify them immediately.
Below we will address several key questions however, if you are a Cleveland Clinic patient, we encourage you to ensure that you have enrolled in our remote monitoring capability.
How many patients has Cleveland Clinic implanted with these specific defibrillator leads?
We have about 1500 patients with these leads.
What is the problem with the leads?
These leads or electronic wires are prone to fracture in a small number of patients which can cause the defibrillator to deliver unnecessary shocks or not operate at all. Medtronic's initial review of reported adverse events found that some deaths and major complications have occurred after the leads have fractured.
How do I know if my lead is defective?
There is no test to predict which lead will fracture. The Food and Drug Administration (FDA) and Medtronic recommend that defibrillator settings be adjusted at each patient's next scheduled follow-up visit with their doctor. Doing so may increase the likelihood that a fracture will be detected before a patient is harmed. Also, Cleveland Clinic patients need to make sure that they are enrolled in our remote monitoring program to ensure the integrity of their device is monitored continuously by Cleveland Clinic staff.
What now?
The Sprint Fidelis leads will no longer be sold or manufactured and any remaining product should be pulled from inventory and returned to the company. Patients who are implanted with this lead are encouraged to contact their physicians for information on their specific case.
Should I get my leads removed?
Often, the problem is so rare or so mild, that it is very unlikely to be harmful to most patients. These lead problems occur at a rate that is considered within the expected range. In addition, replacement of the leads requires a small incision in either the upper chest or groin. This surgery, although also associated with very few problems, still has risks. For these reasons, surgery may not be routinely recommended. For many patients, follow-up visits for lead checks and re-programming options may be a preferred course.
If you are a Cleveland Clinic patient and have concerns regarding your implantable device, you should talk to your doctor about the risks, benefits and alternatives of surgery to replace the device, or have a follow-up visit.
It is critical for Cleveland Clinic patients to utilize our remote monitoring capabilities in order to best manage your health care.If you have a device, and would like to enroll, please contact the device clinic at Cleveland Clinic 800.223.2273 ext. 46483.
Other resources for information about implantable devices are:
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