In October 2007, the U.S. Federal Drug Administration (FDA) recalled defibrillators from Medtronic, Inc., the nation’s largest maker of implanted heart devices. Medtronic stated that one of its more recent defibrillator models was prone to malfunctions in hundreds of patients and may have contributed to five deaths. The cause has been traced to a flaw in a crucial component in one of its more recent defibrillator models.
The FDA announcement, made on October 15, explained that Medtronic Inc. Sprint Fidelis® Defibrillator Leads (model numbers 6930, 6931, 6948 and 6949) manufactured from September 2004 through October 15, 2007 were the subject of a CLASS 1 RECALL. A Class 1 Recall is the most serious recall, involving situations with a reasonable probability that use of the product will cause serious injury or death. Following this announcement Medtronic, voluntarily suspended worldwide distribution of the Sprint Fidelis® family of defibrillators and advised against new implants of the “leads”.
“Leads” are tiny wires that connect the patient’s heart to the stopwatch-size defibrillators. Medtronic said that the leads could fracture inside the patients’ blood vessels, possibly causing the defibrillator to improperly send a massive electrical jolt to the heart. Defibrillators are designed to detect an irregular heartbeat and deliver one or more shocks to restore a normal rhythm. If the device discharges improperly, it can cause fatal complications.
The Sprint Fidelis® leads are used to deliver therapy in defibrillators only, including Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy – Defibrillators (CRT-Ds). According to Medtronic Inc., approximately 268,000 Sprint Fidelis® leads have been implanted worldwide.
Recent and Further Controversy
Medtronic continues to face scrutiny from various governmental agencies. The United States Justice Department (USJD) has been investigating allegations that Medtronic was paying doctors $1,000-$2,000 per patient to implant its pacemakers and defibrillators. In December of 2011, Medtronic reached a $23.5 million settlement with the USJD, basically concluding the investigation.
Starting a Medtronic Defibrillator Lawsuit
If you or someone you know has suffered injury due to the Medtronic Inc. Sprint Fidelis® Defibrillator Leads or may simply have had the recalled leads implanted, call The Rothenberg Law Firm LLP immediately at 1-800-624-8888 or submit an InjuryLawyer.com online free case evaluation. You may qualify to bring a Medtronic Defibrillator Lawsuit for money damages, medical treatment, and other benefits. The initial consultation is FREE of charge. If we agree to handle your case, we are compensated for our services only if you receive compensation for your injuries.
Many of these cases are subject to a Statute of Limitations and are time-sensitive. Therefore, it is imperative for you to please act now to protect your rights.