In 2007, Medtronic voluntarily recalled their Sprint Fidelis defibrillation leads due to the potential for lead fractures. The Sprint Fidelis leads deliver treatment in heart defibrillators. They are mainly used in Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds). The recall does not involve pacemakers made by Medronic.
Medtronic does not recommend that patients using these leads try to replace them. The risks associated with removing the lead and installing a new one outweigh the risks of a lead fracture with the defective devices.
Malfunctioning leads may cause patients to receive unnecessary shocks, or they may not provide the patient with an adequate shock when needed. Five patients have died in connection with a Sprint Fidelis lead fracture.
Do You Have a Lead Fracture?
In September 2008, the Food and Drug Administration (FDA) approved a software update to help identify fractures in malfunctioning Medtronic Sprint Fidelis leads. The software is not a remedy for the problem, but it will make doctors and patients aware of the presence of a fracture. This will enable doctors to take action before the fractured lead causes serious damage to the patient.
The FDA’s software, called the Lead Integrity Alert, gives off a sound when it identifies a lead fracture. This warning signal will sound every four hours until your defibrillator is reset. If a Medtronic Sprint Fidelis lead has been installed for use with your defibrillator, contact your doctor immediately to see if you should be checked for lead fractures.
Legal Action Against Medtronic
Currently, over 225 product liability lawsuits have been filed against Medtronic in relation to their defective Sprint Fidelis leads. Many of these lawsuits are class action cases, representing the personal injury claims of over 600 defendants. Plaintiffs in these lawsuits are accusing Medronic of misrepresenting the safety of their Sprint Fidelis leads and negligently manufacturing leads that are predisposed to breaking due to excessive thinness.
Many victims have suffered serious injuries as a result of receiving unnecessary shocks from these leads, and have been forced to endure excruciating pain. Others have dealt with the anxiety of not knowing if their defibrillator will work when they need it to.
If you have suffered an injury as a result of a defective Medtronic Sprint Fidelis lead, you deserve to be compensated for your injuries. It is important to consult an experienced pharmaceutical injury lawyer immediately to determine the best way to proceed with your case.