Risk of Medtronic defibrillator lead malfunction may be higher for children and young adults
Last week, Medtronic recalled their Sprint Fidelis defibrillator lead after it was discovered that the small electrical wire is prone to fracturing or breaking, which could result in serious injury or death. Medtronic data Initially suggested that the overall failure rate was about 2.3% at 30 months, which means 4,000 to 5,000 people could experience problems. However, new research indicates that the malfunction rate may be substantially higher for children and young adults who received the defibrillator lead wire.
>>INFORMATION: Medtronic Defibrillator Lead Malfunctions
The Medtronic Sprint Fidelis is a small electrical wire, which connects the defibrillator to the heart. About 235,000 patients worldwide still have the defective lead, which could break or erode causing a severe, unnecessary electrical shock to the heart. At least five deaths have been tied to the defective lead.
Defibrillator leads are generally very fragile, and the Sprint Fidelis is much thinner than most other leads which are used. The small diameter is designed to provide for easier insertion, and this has made it particularly popular among doctors who implant defibrillators in children and young adults. However, the leads could come under additional stress in young people, who are more active, increasing the risk of lead fractures.
According to a report published Friday in the Wall Street Journal, data from 32 clinics which specialize in treating children and adults with congestive heart failure, found that the defibrillator lead malfunction rate was 6.7% for 569 individuals followed for 30 months. Some parents have expressed concern over whether their children may now need to severely limit their activities to reduce the risk of a defibrillator lead fracture.
Despite the risk of injury or death linked to the defibrillator leads, experts are not recommending that individuals remove or replace the small wires if they have no evidence that the lead has already fractured or broken. The risks associated with attempting to insert a second lead or replace an existing lead carries a substantial risk of complications. The FDA has indicated that any individuals who believe they may have the Medtronic Sprint Fidelis lead (models 6930, 6931, 6948, 6949) should contact their doctors.
MEDTRONIC DEFIBRILLATOR LEAD LAWSUITS
The lawyers at Saiontz, Kirk & Miles, P.A. are reviewing Medtronic lawsuits nationwide for individuals who are at risk of experiencing a defibrillator lead malfunction. Any defibrillator implanted since 2004 could have the defective wire connecting the device to the heart. To determine if you, a friend or family member may be eligible for compensation, request a free consultation.
