Medtronics Lawsuit Information | Medtronic Recalls Defibrillator Leads

On October 15, 2007, Medtronic, Inc. announced that it was recalling its Sprint Fidelis defibrillation leads. The Medtronic lead recall was due to “the potential for lead fractures.” At the time of the recall, there were reports of at least five deaths associated with the defibrillator leads. The Food and Drug Administration classified the recall as “Class 1,” which is the most serious type of recall and involve situations where there is a reasonable probability that the use of the product will cause serious injury or death.

Lead fractures, or breaks, can cause the defibrillator to deliver an unnecessary shock to the heart, or fail to deliver a shock when one is needed. Following lead fractures, some patients have died and many others have reported experiencing problems including unnecessary shocks and jolts. The following Medtronic defibrillator leads have been recalled due to problems:

• Sprint Fidelis 6930
• Sprint Fidelis 6931
• Sprint Fidelis 6948
• Sprint Fidelis 6949

The thin diameter of the Medtronic Sprint Fidelis leads made these models more popular and desirable for implantation in younger patients, especially children and adolescents. The narrow design of the lead made it easier for physicians to thread through smaller veins. However, the narrow diameter also created a critical problem. The leads are more prone to fracture in younger and more active people. As the heart beats faster in children, adolescents and active people, more stress is placed on these defective leads which are already prone to fracturing. The additional stress may cause these leads to crack or fracture, leading to inappropriate, excruciating shocks. Fortunately children and adolescents make up a small portion of the patients who received the recalled leads. It is estimated that only around 2,000 out of the 268,000 Sprint Fidelis leads that were implanted since 2004 were implanted in patients under the age of 21.

For those children who have the unfortunate experience of receiving an inappropriate shock from a defective lead, the results have a more profound psychological impact than on adult patients. Psychological symptoms in children and adolescents include severe anxiety, depression, problems with relationships and excessive worrying. The shocks are reported to be especially painful and terrifying for children. Such an unexpected, painful experience can lead to an intense fear of additional shocks. Because surgical removal is too risky in most instances, many children, adolescents and active people have altered their lifestyle and stopped participating in their normal activities for fear that they will experience more unnecessary shocks.

We represent all Medtronic recalls clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation case review please call toll free at 1-888-343-5375 or fill out our short online contact form and a Medtronics lawsuit attorney will contact you to answer any of your questions.

Children ICD Medtronic Lead Fractures | Pediatric Heart Leads Recall

Implantable cardioverter-defibrillators (ICDs) are being used with greater frequency in the treatment of children with congenital heart abnormalities and other life threatening ventricular arrhythmia heart problems. Children are at much greater risk of having one of the recalled Medtronic leads fracture because they are more physically active and due to growth issues. A fractured lead that results in inappropriate shocks can have significant psychological and emotional effects especially the younger the age of the child.

Studies have shown that children receiving an inappropriate shock from their defibrillator were associated with reduced mental wellbeing and physical functioning. Receiving an inappropriate shock is the equivalent to being kicked in the chest which can create psychological symptoms even in adult patients.

Some of these symptoms include:
•    Anxiety
•    Depression
•    Excessive worrying
•    Problems with family relationships

Pediatric patients differ in several ways and present different complicating factors compared to adult patients. The Heart Rhythm Society relates several of these factors:

“Patients are often smaller than an adult, the anatomy can be more complex, and there may be unique hemodynamic and physiologic consequences of device selection, lead placement and pacing modality. Further, the emotional and psychological support provided may be as important to care delivery as the technical aspects of the procedure.”

The Heart Rhythm Society goes on and states that these issues are even more important for children under the age of thirteen. The Medtronic Recall of their Sprint Fidelis leads has been even more critical for children with an ICD due to the serious issues involved with removing the leads during an explant surgery.

We are currently representing families of children who have suffered from a fractured Medtronic lead. We represent all Medtronic recall clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Medtronic lawsuit attorney will contact you to answer any of your questions regarding how we can best help your child.