Medtronic Lead Recall: Update letter sent with information about lead performance
Medtronic, Inc. recently issued an open letter to patients who have one of their recalled Sprint Fidelis defibrillator leads. The letter, which is dated May 9, 2008, notifies patients that the risk of lead problems remains small and the recommendations they are making to doctors are unchanged. More detailed information about lead performance was sent to physicians the same day, to update their October 2007 communication, now that six months have passed since the recall.
>>INFORMATION: Medtronic Defibrillator Lead Recall
The information provided to physicians who treat those with cardiac defibrillators indicates that Medtronic’s continued analysis of data has found that the probability of a Sprint Fidelis lead fracture through 30 months is 2.5%, which is only minimally more than the original estimate of 2.3%. Although the risk remains small, given the number of leads which have been implanted, 5,000 people could expect their lead to fracture within the first two and a half years.
>>LINKS: Medtronic Patient Letter
Medtronic Physician Letter
As more leads reach 33, 36 and 39 months post-implant, additional information will be available to provide a better understanding of the lead’s performance. In the meantime, the only reassurances provided to patients are Medtronic’s patient management recommendations, which are designed to provide advance notice of a lead failure. However, the letter indicates that more than half of the fractures detected will be found with less than two days before the therapy fails or with no notice at all.
Westby G. Fisher, M.D., an independent internist, cardiologist and cardiac electrophysiologist who contributes to a blog as “Dr. Wes”, discussed the Medtronic letter he received in a recent post on May 13, 2008:
By Medtronic’s analysis of a typical 1000-patient ICD clinic, over the next 12 months, nine (9) patients can be expected to have an anode or cathode failure and half of those patients will have little warning of an impending fracture.
The implications of these recommendations are far-reaching, for it now seems the fault with the lead was not a physician implant technique problem as originally surmised, but rather a design flaw. Further, when it comes to replacing these patient’s defibrillator batteries over the next four or five years, electrophysiologists will likely be advised to replace the 6949 lead (Medtronic Sprint Fidelis) with a more reliable defibrillator lead model, like the 6947 (Medtronic Sprint Quattro Secure), increasing the difficulty of a typical device battery change procedure.
MEDTRONIC LEAD RECALL ATTORNEYS
The attorneys at Saiontz & Kirk, P.A. represent individuals throughout the United States who had a Medtronic Sprint Fidelis Lead (Models 6949, 6948, 6931, 6930) implanted to connect their defibrillator to the heart. Although nearly all people who had one of the leads implanted have been notified about the recall and are continuing to follow up with their physicians, many still have not consulted with an attorney to review their legal rights. To speak with an attorney and review a potential case, request a free consultation and claim evaluation.
