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On October 15, 2007, Medtronic issued a recall of its Sprint Fidelis defibrillator leads as a result of at least five patient deaths in which a lead fracture may have been a contributing cause. Sprint Fidelis Leads are certain models of cardiac electrodes (thin wires) that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. The recalled leads have been implanted in over 200,000 patients since 2004. Most patients with Medtronic defibrillators since 2004, and most patients who received Medtronic defibrillators since then have these leads. A small number of Sprint Fidelis leads are also used with defibrillators made by manufacturers other than Medtronic.
Medtronic estimates a 2.3 percent failure rate in patients with the Sprint Fidelis lead, or 4000 to 5000 people, will experience a lead fracture within 30 months of the device implantation. Replacement of the lead is a serious and delicate procedure which is far more dangerous than replacing the device itself because the lead wires are thread into the interior chamber of the heart.
Generally, patients with heart devices are issued device identification cards that will contain information about their heart device and leads. Patients can check this wallet card for the model number to see if their leads are under recall. The recalled leads are Sprint Fidelis Lead Model Nos. 6930, 6931, 6948 and 6949. These numbers may be shown at the beginning of a longer set of numbers on a patient's identification card.
Complaints against the company allege that a design defect is responsible for the lead fractures. The complaints also allege that Medtronic failed to act timely in recalling the lead as it has known of a large number of failures of the device since at least the end of 2006.
If you would like additional information regarding the aforementioned recall, or would like to speak to an attorney regarding bringing a potential case against Medtronic associated with the implantation of a Sprint Fidelis lead, please contact me directly.
Claudine Q. Homolash has successfully represented hundreds of patients across America who received faulty or recalled medical devices, including implantable cardiac defibrillators and pacemakers.
1 comment:
We represent multiple clients who have experienced unnecessary shocking due to Medtronic's faulty lead. One client, in particular, was shocked over thirty times.
What is more frightening is the fact that the Supreme Court recently held oral argument on whether federally approved medical devices are broadly shielded from product-liability lawsuits. If the Supreme Court agrees with this big business position, many people who are injured due to faulty medical devices will be left with no recourse. It seems that big business has bought the FDA since it recently admitted that it cannot keep up with advances in science! The report, from a subcommittee of the FDA's outside Science Board that included members and advisers from industry as well as academia, said the agency "cannot even keep up with the advances in science." An appendix to the report said the FDA conducted twice as many inspections of food facilities in 1973 as it did of all facilities -- including food, drugs and medical devices -- in 2006.
In Riegel v. Medtronic. The Riegel case was brought by a New York man, Charles Riegel, who was injured when a Medtronic catheter burst during a 1996 angioplasty procedure. Riegel, who died in 2004, asserted the catheter had design flaws and that labeling instructions for the device were misleading.
Allison Zieve, a Washington-based attorney representing Riegel, labored to convince the justices that federal law allowed Riegel to sue Medtronic over the device, which had received so-called premarket approval from the Food and Drug Administration.
"It is clear that Congress didn't want any additional requirements", Justice Antonin Scalia said, indicating he thinks Congress wanted the FDA to regulate medical devices without interference from state regulators or courts.
A majority of the Supreme Court appeared to support this view.
The BIGGER QUESTIONS - if the FDA has admitted that it can't protect the people and companies can avoid liability by having its products FDA-approved, what protections are afforded to the users of these products? What incentives do medical device companies have to protect the end user?
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