Medtronic announced it was suspending sales of the Sprint Fidelis lead on October 15, 2007. This was an essential component in the implantable defibrillators that the company sold. According to the company, the lead (a wire that connects the defibrillator to the heart) could break or fracture, which may deliver a massive electrical jolt. This may be fatal in the worst-case scenario or lead to extreme pain in patients. The implantable Medtronic defibrillators have used the Sprint Fidelis lead since 2004, and those patients who have received this defibrillator are likely to have these faulty leads.
The estimates place the number of Medtronic Sprint Fidelis leads worldwide at about 268,000, with the United States making up about 172,000 of these implanted defibrillators. If you have the following model numbers on your information card, this Medtronic recall may affect you:
- Model 6930
- Model 6931
- Model 6948
- Model 6949
The initial estimates place the number of people who will experience issues with their lead in the first 30 months at around 4,000 to 5,000. The estimates of the company place the number of patients who have issues at approximately 2.3% of all users.What happens during a Sprint Fidelis fracture?
Those patients who experience a Sprint Fidelis lead fracture have three possible outcomes:
- The patient is lucky and the implantable defibrillator starts to beep, urging the patient to seek out immediate medical attention
- The lead fracture leads to massive electrical shock, this leads to sudden and extreme chest pain
- The third outcome is the most disturbing. The fracture will lead to the depletion of the Medtronic defibrillator’s battery. In the event that this happens, the defibrillator may not be able to provide the necessary life-saving shock to the heart. This may be fatal
Medtronic is a global medical product manufacturer. The company’s annual sales are over $12 billion. The company is the largest supplier of heart devices such as pacemakers and defibrillators. The Medtronic Sprint Fidelis lead is a very fragile electrical wire. The lead wires in the Medtronic Sprint Fidelis defibrillator were designed to be thinner than the traditional wires to guarantee easier insertion. A break or fracture in the wire may lead to a misreading of the heart rhythm data.The risks of surgical removal considered less risky than leaving the device in place
While the Medtronic lead problems carry significant risk, experts are not recommending that the wires be removed. Leaving the potentially defective wire in place is less risky than removing the lead from veins that carry it to the heart. The reason behind this is that scar tissue builds up around the lead after the initial implant, this may increase the risk of damage to the heart muscle, or the risk of a vein tear if the wire is removed.Medtronic defibrillator lawyers
Medtronic has had issues with their defibrillator systems before. A previous recall came in 2005. Additional recalls of leads came in the 1980s and again in 1991. If you or someone close to you has a Medtronic Sprint Fidelis defibrillator, you may be eligible for compensation. Contact Rosenfeld Injury Lawyers today for a complimentary case evaluation.