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Defibrillator lead recalled as a defective medical device

When it comes to their medical well-being, most patients place the responsibility in the hands of experts such as doctors, hospitals and medical device manufacturers. There are times, though, when the experts fail to act appropriately, and in turn serious injury can occur. Currently, a defective medical device is at the center of a lawsuit that even has a California judge weighing in.

St. Jude Medical, a medical device manufacturing company, is under fire concerning one of its faulty products. Apparently, they recalled one of their defibrillator leads -- the Riata defibrillator lead -- in 2010 due to faulty wires, but not before the damage was already done. According to plaintiffs who have filed a lawsuit against the company, the device's wiring caused perforations in the tissue for many patients who had been implanted with the lead. One man reported that his lead's flaws caused him to be shocked over 60 times before he ultimately had it replaced.

Between 2002 and 2008, reported incidences of perforations as a result of the Riata lead rose 6%. Moreover, many perforations were reported incorrectly to the FDA, and some were not reported at all. It wasn't until 2011 that the device was officially recalled. More than 30 patients were injured or killed due to the device.

The lawsuit alleges that St. Jude Medical was aware of the flaws in its Riata defibrillator lead, but failed to warn patients and doctors of the serious implications of continued use. When knowledge of a defective medical device is not disclosed, serious injury and even death can be the result. In some cases, when a faulty device results in a California victim's death, family members may choose to file a wrongful death claim on behalf of their lost loved one. Financial recourse may not be able to bring back a lost loved one, but it can help cover medical bills related to the incidence and, for some, may serve as a sense of justice for the victim.

Source: massdevice.com, Riata lawsuit claims stand against St. Jude Medical, Brad Perriello, Jan. 27, 2014

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