Medtronic Defibrillator Lead Lawsuit | Sprint Fidelis Leads Recall

On October 15, 2007, Medtronic announced a recall of its Sprint Fidelis leads. The Medtronic defibrillator lead recall was announced 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.

We are continuing to actively work on getting out information regarding the importance of the pending Medical Device Safety Act which had a Senate hearing this summer. This important legislation will help not only patients with defective Medtronics Fidelis leads, but also thousands of other patients who have experienced problems and injuries due to defective medical devices.

A defibrillator contains two components. The first part is a computerized device that monitors the patient’s heart rhythms and makes the decision whether an electrical shock needs to be given. The leads are wires that doctors thread through the patient’s veins leading to the heart. Leads stretch from the device through the veins to the heart. It both receives the information of the abnormal heart rhythm and sends the shock to the heart when an abnormal heart rhythm is detected.

Defibrillator Problems

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 defibrillators have been recalled due to problems with the leads:

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

Approximately 268,000 Fidelis leads have been implanted worldwide, including 172,000 Sprint Fidelis leads implanted in the United States. At the time of the recall, Medtronic had confirmed 665 chronic fractures in returned leads and estimated that 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. As of March 13, 2009, the FDA’s MAUDE database, which contains reports of adverse events involving medical devices, had 107 Medical Device Reports (MDRs) that include allegations that the defective Fidelis lead may have caused or contributed to a patient’s death.

If you or someone you know has experienced defibrillator problems with a Sprint Fidelis lead you may have important legal rights. Many patients have experienced a lead fracture which can cause painful and sometimes life-threatening shocks to the heart or alternatively not provide a shock when needed. Many patients have had to undergo an additional surgery due to a lead failure. We are currently representing patients who have a defective Medtronic Fidelis lead in filing individual Medtronic recall lawsuits.