Earlier this month the FDA issued a Class I Recall on defibrillator wires that connect implanted defibrillators to the heart. The wires, (leads) were manufactured by Medtronic Inc., one the leaders in this market. The Sprint Fidelis leads were linked to several reports of patients receiving unwarranted shocks from their defibrillators. Plaintiffs’ attorneys have begun filing lawsuits against the manufacturer and with almost a quarter of a million of these leads implanted I expect more lawsuits to be pursued in the future.
Leading heart device attorneys have filed suits in federal courts of Puerto Rico and Minneapolis. There have been allegations that that Medtronic was made aware of problems with the defective leads as early as January of this year, but failed to act until this month. Medtronic claims that implant method could greatly contribute to the likelihood of fracture.
Before approving the Sprint Fidelis models, the FDA reviewed results from animal tests and extensive engineering “bench” studies, including 400 million repetitions of a bending motion designed to answer questions about the devices’ strength, said Megan Moynahan, chief of the FDA branch that oversees defibrillator leads. Because the fracturing issue is “extraordinarily rare,” a human clinical trial was unlikely to find it, she said.
For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.