If you are reading this page, then you are likely affected by the recent product recall of the Medtronic "Sprint Fidelis" ICD lead family. The model numbers for the ICD lead under advisory are 6930, 6931, 6948, 6949 and if you have this lead implanted, then one of these model numbers will appear on the implant I.D. card Medtronic should have sent you. This defibrillator lead was designed to be the smallest ICD lead on the market allowing ostensibly for easier implantation with less trauma to the patient and lower long term complications that can be seen with larger leads. On Monday October 15, 2007 Medtronic announced a voluntary product advisory for this lead due to a greater then expected chance for electrically conducting wires in this lead to fracture. 90% of the wire fractures in this lead affect the pace/sense conductors of this lead. These are the wires in the lead that the defibrillator uses to both pace the heart and sense abnormal rhythms. 172,000 of these leads have been implanted in the United States since this lead was originally released to market on September 28th 2004.
A conduction fracture in the pace/sense portion of an ICD lead can potentially be a serious issue. If the pace/sense conductors of an ICD lead fracture, the defibrillator will sense high frequency electrical noise. The defibrillator will interpret this noise as a potentially fatal heart rhythm and may attempt to shock the patient - despite the patient being in normal rhythm at the time of the shock. In general, a series of inappropriate shocks will occur with several shocks occurring one after the next. A fracture of this lead will prevent the ICD from being able to normally pace the heart. The ICD rarely at other times however may attempt to pace the heart at very fast rates when this fracture occurs. Under rare circumstances, the failure to normally pace, the possible rapid pacing or the inappropriate shocks can produce a life threatening rhythm in the patient which the ICD may fail to recognize given the sensing lead fracture.
Medtronic, the ICD lead manufacturer is recommending that patients with this ICD lead undergo reprogramming of their defibrillator. This reprogramming will make the defibrillator less sensitive and may help prevent some inappropriate shocks should the lead fracture. This reprogramming however will have no effect on the risk of the fracture developing nor will it prevent inappropriate shocks or failure to appropriately pace in all patients. Medtronic has not made recommendations on the decision whether or not a physician should replace the lead under advisory. This decision is currently being made on a case by case basis depending on the circumstances of the patient involved in this advisory.
The risk of lead fracture at this time (October 2007) appears to be 2.3% over a 30 month period. As longer follow-up data on this lead is collected it is likely that the failure rate for this lead will rise in the future. Previous failures of other pacemaker lead systems have shown that lead failure rates increase the longer a lead is implanted with failure rates often times increasing dramatically in later years of follow-up. Failure rates for this lead appear to correlate with patient age. In patients under the age of 21, 3.8% of leads failed at 30 months versus 2.5% for patients under 58 years of age versus 1.6% for patients over 58 years of age.
At this time we are recommending all patients with this ICD lead make an appointment to see either their cardiologist or to schedule an appointment with this office. At the time of this visit a nurse practitioner will discuss the options available to you including the options of ICD lead replacement versus ICD device reprogramming with continued follow-up.
In order to facilitate the scheduling of patients who have this lead who need to be seen, we ask you to please send us an e-mail with your name and phone number and we will contact you with an appointment to discuss the options with your ICD and lead system. Please note, your e-mail is going to our scheduling personnel who cannot comment on specific medical issues so all we need is your name and phone number and a notation that you have a lead under advisory and someone will contact you shortly. Click on the following link to send us your information: Sprintlead@atrial-fib.com.
As part of this lead advisory, we have developed a set of guideline regarding how best to manage patients with this lead in place including options for lead replacement. These guidelines can be seen by clicking on the link below. We are also in the process of sending a letter to our patients with this lead in place instructing them to make an appointment with us or their cardiologist so that their ICD can be reprogrammed and to further discuss the options available to them regarding this lead. To see this letter click on the link below.
To see our current guidelines for management of this lead, click here.
To see our letter to patients click here.
To send us an e-mail for an appointment click here.
Page posted for worldwide Internet dissemination October 15, 2007. Revised 10/21/2007. Copyright Florida Electrophysiology Associates. This page cannot be reproduced without express permission of the authors. Content is informational in nature only. Specific advice and health care decisions require individualized advice and can only be made via specific one on one professional interactions with health care professionals.