Medtronic Inc. announced today that it was suspending sales of the Sprint Fidelis lead, a vital component of its implantable defibrillators. According to the company, the lead can fracture, causing serious and sometimes fatal injuries in patients. At least five deaths have been linked to the defective Sprint Fidelis lead.
The Sprint Fidelis lead is a wire that attaches a Medtronic implantable defibrillator to the heart. The Sprint Fidelis lead has been used in implantable Medtronic defibrillators since 2004. It is a component of cardiac defibrillators — or complex devices with defibrillation capacity — and not conventional pacemakers. Some patients with congestive heart failure use devices that included this defibrillation ability, and those were among the machines that use the Sprint Fidelis lead.
Medtronic decided to suspend sales of the Sprint Fidelis lead after its own data analysis revealed that the leads had a problem with fracturing. If a lead fractures, it can create a massive electrical shock that causes the patient extreme and sudden chest pain. In the worst case scenario, the fracture of a Sprint Fidelis lead can deplete the Medtronic defibrillator’s battery. If this happens, the Medtronic defibrillator can fail to deliver a necessary, life-saving shock to the heart. According to Medtronic’s own estimate, about 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis lead will experience fracture within 30 months of having a defibrillator implanted. Those patients whose Sprint Fidelis lead fractures will require a dangerous surgical procedure to have the wire replaced.
The Medtronic implantable defibrillator analysis is not the first time that the Sprint Fidelis lead has caused concerns. Earlier this year, another study published by the Minneapolis Heart Institute found that a significant number of patients with the component had experienced painful shocks when the defibrillator fired unnecessarily. Medtronic was made aware of the Minneapolis study’s findings, but did not believe that there was enough evidence to reach any conclusions about the performance of the Sprint Fidelis lead. However, in March, the company did send doctors a letter outlining concerns with the defibrillators.
In addition to suspending sales of the Sprint Fidelis lead, Medtronic is also recalling all unused leads on the market. But for patients with the defective Sprint Fidelis lead, the solution is not so simple. Removing and replacing a lead is extremely risky, and can cause fatal complications. For that reason, Medtronic is urging physicians to reprogram the defibrillators to minimize the problem. Medtronic said the new programming would allow the implantable defibrillators to better monitor and warn of problems with the Sprint Fidelis leads. Medtronic said that it will pay to replace fractured Sprint Fidelis leads, and it will cover up to $800 in medical expenses not covered by a patient’s insurance. However, Medtronic will not pay to replace Sprint Fidelis leads that are functioning properly.
This is not the first time problems have arisen with Medtronic implantable defibrillators. In 2004, the company recalled two models of its implantable defibrillators because they had a problem charging. Those defective Medtronic implantable defibrillators have been tied to at least four deaths.
<You can leave a response, or trackback from your own site.
