Medtronic Cardiac Leads
US, Canada and Puerto Rico
Defibrillators can be miracle devices for anyone who has a serious heart condition. If you suffer from an irregular heartbeat that may threaten your life, a defibrillator works by automatically delivering a shock that restores you heart to its normal rhythm. While a defibrillator can save your life, it has to work properly to do so.
In October 2007, the critical elements of a defibrillator, the lead wires, were recalled by their manufacturer, Medtronic. The lead wires, called Sprint Fidelis leads, are cardiac electrodes (thin wires) that connect the defibrillators to your heart. If you or a loved one has Sprint Fidelis leads as part of your defibrillator system, you may be in danger of losing your emergency rescue system and should contact the defective product lawyers at Balkin & Eisbrouch, LLC.
Dangers of Sprint Fidelis Leads
This product recall exposed many complications of the defective leads. These included multiple or unnecessary shocks because of improper sensing and failure to deliver shocks when a patient was experiencing:
- Life-threatening arrhythmia
- Dizziness
- Fainting
- Heart palpitations
In many cases, the complications were caused by leads that were cracked or broken. The result of this product defect is more than 170,000 Americans who are:
- In danger of losing their emergency rescue system
- At risk of serious damage to their hearts
- At risk of death
What you Should Know
If you or a family member had (or still has) a defibrillator connected to a Medtronic Sprint Fidelis lead, here are a few things to keep in mind:
- Even if your defibrillator is manufactured by a different company, you may have been implanted with a Medtronic Sprint Fidelis lead.
- This recall does not include defibrillators themselves, pacemakers or other Medtronic devices that do not contain a Sprint Fidelis lead. That being said, a number of Medtronic pacemakers and defibrillators have been recalled in the past few years.
- Four Sprint Fidelis lead models were recalled: 6930, 6931, 6948, and 6949. Doctors were instructed to stop implanting them and return any unused products to Medtronic. You can check your identification card, which will include the model numbers for the lead attached to your defibrillator.
Removing the defective leads is not the best option, according to the Food and Drug Administration (FDA). This is a risky action since the leads are threaded through your heart. Alternatives include:
- Closely monitor the recalled models for signs of fracture
- Surgically add a replacement lead and “cap off” the Medtronic Sprint Fidelis lead inside your chest
If you have been injured by defective leads, please contact the defective products attorneys at Balkin & Eisbrouch LLC, serving clients in the United States. We can answer your questions and help you protect your legal rights as a victim of a defective product.
