St. Jude Medical Defibrillators Found to be Susceptible to Failure
A new study has shown St. Jude Medical defibrillators are prone to malfunction, either by administering unnecessary high-voltage shocks or failing to provide lifesaving therapy. Special wires called “leads” have a high tendency to fail, resulting in traumatic discomfort at best and fatal heart problems at worst. Internal insulation breaches may not be detectable, while the medical device maker, Durata, continues to defend the device’s safety and durability.
A thorough investigation discovered this specific mechanism was responsible for 137 of the 1000 reports of lead failures, and even caused 1 patient’s death. This is the only documented casualty and it details how the patient’s device failed to administer the high-voltage shock he needed to save his life.
The report was based on information assembled from publicly filed reports in the FDA’s MAUDE database, which is the only open source for reporting and accessing individual injury and malfunction records. While companies must release general information regarding the status of their products, they are not required to disclose specific details. The investigation revealed, shockingly, 93% of Durata failure reports had insulation breaches.
Federal law dictates manufacturers and device makers must disclose any case involving serious injury or death in regard to their products. Holding these negligence companies responsible for their reckless behavior is essential in protecting public health and safety, and it is a mission our firm is proud to support.
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Injured in Toledo? Contact Our Knowledgeable Legal Team
If you have a defibrillator, we know how much you rely on it to save your life at any given moment. Failure is not an option. This is why our personal injury lawyers are devoting to protecting victims who have suffered as a result of another’s negligence or misconduct. With your life on the line, there is simply no time to waste in going after the compensation you deserve and preventing this from happening to another person ever again.
Have you been injured due to a dangerous medical device? Contact our personal injury lawyers of Williams DeClark Tuschman Co., L.P.A. today by calling (419) 318-0772.