Device name: Sprint Fidelis Defibrillator Lead
Approved uses: Approved for use in a defibrillator system with a device implanted near the shoulder and one or more leads, or wires, connecting the device to the heart for the purpose of defibrillation in the event of cardiac arrest in those at risk.
There is a small chance of fractures in particular locations on the Sprint Fidelis lead, which can cause the device to either deliver an unnecessary electrical jolt or fail to provide a life-saving one to a patient in need.
Related topics: Medtronic Defibrillator
Sprint Fidelis Defibrilator Lead
On October 15, 2007 Medtronic announced it was voluntarily suspending distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected in a number of patients. This voluntary defibrillator lead recall came after Medtronic identified five patients whose deaths may have been related to a fractured Sprint Fidelis defibrillator lead. As a result of Medtronic’s action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company, according to the Food and Drug Administration (FDA). While the FDA has not suggested or mandated the Sprint Fidelis lead me removed from the more than 268,000 patients who are implanted with the lead, those patients are encouraged to contact their physicians for further information.
Medtronic Sprint Fidelis Defibrillator Lead Recall Could Effect Hundreds of Thousands
On October 15, medical device maker Medtronic announced a safety recall of a type of wire used in its implantable defibrillators, called Sprint Fidelis defibrillator leads. The defibrillators are implanted directly into the chests of patients with heart problems. They’re meant to stop heart arrhythmia by delivering an electric shock that jolts the heart back into proper functioning. The Sprint Fidelis defibrillator lead is the part that sends the shock from the device to the heart. Unfortunately, the company said, its Sprint Fidelis defibrillator leads break more often than they should, which can lead to sudden and painful shocks at times when nothing is wrong — or no shock at all when it’s needed to save a life.
Dangers of the Defibrillator Leads
Medtronic�s press release says at least five patients may have died because this defect in Sprint Fidelis defibrillator leads kept the defibrillator from doing its job — saving their lives. Hundreds more have felt the effects of the defective lead, which include audible beeping from the chest and painful, unnecessary electric shocks to the heart at inappropriate and random times. Quoted in the Los Angeles Times, cardiologist and FDA consultant Dr. William Maisel said his patients had described the shocks as similar to being kicked by a horse or struck by lightning — impossible to just shrug off, especially when they come at a rate of 30 or more an hour, as some patients have reported.
In its press release, Medtronic estimated that 268,000 people worldwide have had the Sprint Fidelis defibrillator leads implanted since 2004. Of these, they say 2.3 percent of all patients with the implants can expect the Sprint Fidelis defibrillator lead to break within 30 months (two and a half years) of receiving it. Those people will need risky, expensive surgery to fix the problem; the replacements for the Medtronic defibrillator leads will have to be either an older model from Medtronic, the Quattro, or other manufacturers’ leads. Patients who haven’t had a Sprint Fidelis defibrillator lead fracture may be able to solve the problem by having doctors reprogram their defibrillators. As part of the Sprint Fidelis defibrillator lead recall, Medtronic has announced that it will pay up to $800 of costs not covered by insurance for the surgery to replace broken Sprint Fidelis defibrillator leads. However, the company won’t pay for costs above that, or for surgeries to replace Sprint Fidelis defibrillator leads that are not yet broken.
Extensive Risk for Defibrillator Leads in Younger Patients
Research has suggested that younger patients may be in even greater danger from this defect in Sprint Fidelis defibrillator leads. A defibrillator’s job is to stop hearts from beating too fast by shocking them back into rhythm; younger people’s hearts tend to beat a little faster naturally, and also because younger people tend to be more active. As a possible result, an Oct. 19 article in the Wall Street Journal reported, researchers have found a 6.7 percent failure rate for the Sprint Fidelis defibrillator leads, almost all in patients under 21. That number comes from an independent survey of pediatric heart specialists by Dr. Wayne Franklin of the Northwestern University Feinberg School of Medicine — undertaken after Dr. Franklin noticed unusually high failure rates for the Sprint Fidelis defibrillator leads among his pediatric patients. The data is backed up in part by Medtronic�s own numbers, which found a 3.8 percent failure rate for a particular model of the Sprint Fidelis defibrillator lead in patients under 21; the overall failure rate was just 0.8 percent.