Medtronic Sprint Fidelis leads have been linked to at least 5 patient deaths and hundreds of malfunctions and injuries.

What are Defibrillator leads?

A defibrillator is a tiny implantable heart device placed beneath the skin in the shoulder area. These work to keep patients alive by monitoring cardiac rhythms. If the defibrillator senses an unnatural heart rhythm it emits an electric shock to stimulate the heart back to beating normally. Defibrillator leads are insulated wires connected to the device. These are networked, by the doctor, through the veins to connect the defibrillator to different parts of the heart. The leads thus connect the defibrillator to the heart, and work to process information of abnormalities in heart beat and correct a potentially life threatening situation by emitting a shock to the heart when it senses an unusual rhythm.

Medtronic is a Minnesota based Fortune 500 medical technology company that manufactures pharmaceutical drugs as well as medical devices, including a range of defibrillator leads.

Problems with Medtronic Leads

Medtronic Sprint Fidelis defibrillator leads have been reported to breakdown and fracture. A fractured lead not only fails to send a life saving shock to the heart during a dangerous situation, but may also emit a massive painful shock resulting in heart injuries or even death.

The FDA confirmed that the cardiac wires were prone to breakage, resulting in defibrillators emitting unnecessary shocks or malfunctioning. The company has confirmed 5 deaths linked to the broken Sprint Fidelis leads. The FDA has confirmed 599 reports of injuries associated with defibrillator leads. According to the FDA, reports of breakdowns have been observed in less than 1 percent of patients implanted with these leads and the agency says it cannot confirm if this rate will remain the same or increase over the years as these implanted leads get older. According to estimates by Medtronic, approximately 2.3 percent of patients who implanted with the lead may experience a breakdown of the lead within 30 months from the date of implantation.

An approximate 235,000 people have been implanted with these Sprint Fidelis defibrillator leads. Those whose leads have not yet malfunctioned are not recommended to undergo surgical removal of the lead due to the risk associated with the surgery. The FDA advises doctors to weigh the benefits of continuing use of the lead against the risk of having it removed, or to disable the lead so that it no longer functions.

In 2007, Medtronic removed its Sprint Fidelis defibrillator leads from the market. The company has chosen to call this a “voluntary suspension of distribution of the leads” rather than a recall. It has advised doctors to stop implanting the defective leads. The company has not settled any of the Sprint Fidelis defibrillator lead lawsuits pending against it. In January 2009, a Minnesota court order dismissed Medtronic Sprint Fidelis lawsuits citing federal preemption over state laws, but the fight to hold Medtronic accountable for its defective leads is ongoing.