According to a June 10 Medtronic field safety notice, there is a low likelihood of malfunction in certain cardiac resynchronization therapy pacemakers (CRT-Ps). Medtronic is asking hospitals to return certain lots of the Consulta and Syncra devices manufactured between April 1 and May 13, 2013, after discovering a manufacturing problem that could prevent the device from functioning properly.
An “out-of-specification” weld on the devices could indicate that the devices aren’t properly hermetically sealed, allowing body fluids into the device and causing malfunction. “If this happens, it may cause loss of pacing output, which could potentially result in return of symptoms, including: fainting, or lightheadedness, dyspnea (shortness of breath), fatigue, edema (swelling),” according to an Australian Therapeutics Good Administration warning.
Medtronic says that the probable rate of malfunction is very low, affecting only about 1-2% of the devices, and as of June 21, the company has not received any reports of device failure due to the defect.
The company states that the manufacturing defects are confined to the two models specified and does not affect any other model or device. Initially, Medtronic had estimated that fewer than 700 patients had been implanted with the potentially defective devices, and later lowered that number to about 265. According to a company spokesperson, only about forty-four of those devices are in the U.S.
Medtronic released an updated notice on July 1, issuing new recommendations for patient care, telling doctors to warn their patients to seek immediate medical attention if they experience any of the symptoms of device failure. Medtronic also recommends that healthcare providers make case-by-case decisions when considering prophylactic replacement of any implanted devices and that they continue with routine follow-ups for these patients.
According to the U.S. Food and Drug Administration, there are about 1900 of the affected devices “in commerce.” The FDA considers this a Class II recall, defined as a measure reserved for “products that might cause a temporary health problem, or pose only a slight threat of a serious nature.”
Unfortunately, this recall does not sit well with consumer advocates who can’t help but notice how often Medtronic has been in the news as of late. The medical device giant has been battling lawsuits over their Infuse bone grafts and defibrillator leads in the past few years alone.
If you or someone you love has suffered a major medical complication because of a Medtronic product, it is important to know that you are not alone. The litigation process will require a competent and aggressive attorney to secure your rights and get you the compensation you deserve. To learn more about filing a Medtronic lawsuit call the experienced Medtronic lawsuit lawyers at Phillips Law Firm today. Call us at 1-800-708-6000. Our national Medtronic lawsuit attorneys are waiting to assist you 24/7, offering a free case evaluation.