St. Jude Medical (subsidiary of Abbott Laboratories) received a warning letter from the US Food and Drug Administration (FDA) this week about issues involving its defibrillator batteries that have been seen to fail prematurely and without warning. This is a danger that poses a significant risk to the health and lives of patients. To date, …. Read More
May Cause Sudden Cardiac Arrest
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According to a warning letter sent by the FDA to Abbott Laboratories (owner of medical device manufacturer St. Jude Medical, responsible for 400,000 implantable defibrillators), reported that St. Jude downplayed defibrillator battery problems and sold defective devices for years before issuing a recall in October 2016. The defect stems from the lithium-based batteries that power …. Read More
On January 9, 2017, the FDA announced that patients implanted with St. Jude Medical’s radio frequency-enabled implantable cardiac devices and corresponding [email protected] Transmitters may be vulnerable to cybersecurity issues—potentially leading to rapid depletion of the battery powering the device. This isn’t the first problem the medical company has encountered with its implantable defibrillators, however. In …. Read More
Debbie Burke, a Baltimore native and mother of five, was implanted with a heart defibrillator manufactured by St. Jude. Little did she know, Burke received an older version of the device that is prone to premature battery failure. Despite St. Jude having reportedly fixed the problem in 2015, the company continued to sell older versions …. Read More
Following the deaths of two patients implanted with a St. Jude Medical defibrillator, the FDA has issued a warning concerning abnormal battery depletion in certain of the company’s Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). Affected devices include several models manufactured before May 2015 that may be prone to premature battery failure—some …. Read More