Medtronic Heart Defibrillators with Sprint Fidelis® Leads

Sprint Fidelis® Leads – a major component of Medtronic heart defibrillators implanted in an estimated 268,000 heart patients between 2004 and 2007 – have been recalled effective October 15, 2007, by the U.S. Food and Drug Administration (FDA). Look on  your card for the numbers 6930, 6931, 6948 or 6949.

Sprint Fidelis Leads are thin wires that connect an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart.  These heart implants are used to treat abnormal heart rhythms that can cause the heart to stop suddenly.  The recall does not affect patients with pacemakers or Medtronic defibrillators that do not rely on Sprint Fidelis leads (including those with Sprint Quattro leads).  Sprint Fidelis leads were introduced in 2004 because Medtronic believed the thinner wires would be easier for doctors to implant than the thicker Quattro leads.

Contact Your Doctor and an Experienced Personal Injury Attorney

As part of the Medtronic Sprint Fidelis heart defibrillator lead recall, doctors have been advised to stop implanting them because fractures have been detected in a number of implanted leads.  Patients are advised to see their physician to monitor the status of their implant and to consult an experienced personal injury lawyer with a strong background in medical device injury cases to determine what legal remedies may be available. Call Faris & Faris at 1-866-250-1786 (toll free) for a free case evaluation.

Breaks or fractures in the lead may cause inappropriate shocks or result in a loss of therapy, such as pacing or shocking.  The device may even stop working entirely.  The FDA has labeled this a Class 1 recall because “there is a reasonable probability that use of the product will cause serious injury or death,” according to the FDA Web site (www.fda.gov/cdrh/recalls/recall-101507.html).  At present, five deaths have been blamed on the faulty leads.

Patients who are unsure whether their implant uses one of the Sprint Fidelis leads should contact their doctor or check the product identification card they received with their implant and are advised to carry with them.  If the card contains one of the following sets of numbers – 6930, 6931, 6948 or 6949 – it is important to contact a doctor as soon as possible.

Minnesota Heart Defibrillator Study Helps Reveal the Issue

Doctors at The Minneapolis Heart Institute studied the incidence of lead failures in the Sprint Fidelis models compared to the Sprint Quattro models and published the results in the Spring 2007 issue of the Heart Rhythm Society Journal.  The study disclosed that between September 2004 and February 2007, 592 patients were implanted with Sprint Fidelis leads – 583 of which were Model 6949 leads. Six patients subsequently experienced Sprint Fidelis Model 6949 lead failures within four to 23 months of implantation. 

The study compared the survival of the Sprint Fidelis Model 6949 leads implanted to the survival of 285 Sprint Quattro Model 6947 leads implanted between late 2001 and early 2007. The failure rate for the Sprint Fidelis Model 6949 lead was between one and two percent during the first two years after implantation and was 10 times greater than that of the Sprint Quattro Secure Model 6947 lead.  The study said most lead failures appear to involve breaks or fractures of the PACE-sense conductor or coil, a small diameter wire that is subject to stress damage both during and after implantation.

For more information on this issue…

www.fda.gov/consumer/updates/medtronic101507.html

www.fda.gov/bbs/topics/NEWS/2007/NEW01724.html

or contact us here

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