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Faulty St. Jude Riata Defibrillator Leads Eyed for Link to Heart Infections

Faulty St. Jude Riata Defibrillator Leads Eyed for Link to Heart Infections September 11, 2017. By Anne Wallace.
Washington, DC: Premature Insulation Failure in recalled St. Jude Medical Riata Defibrillator (ICD) Leads has been tentatively linked to polymicrobial endocarditis, a serious, often deadly condition that causes inflammation of the heart lining, muscles and valves. The decayed insulation on the electrical leads that connect the pacemaker to a patient’s heart may be a fertile breeding ground for bacteria and fungi that can attack a patient’s heart.
Read [ Faulty St. Jude Riata Defibrillator Leads Eyed for Link to Heart Infections ]

Insulation Failure, Battery Failure and Cyber Hacking - A Triple Threat for Pacemaker Patients

Insulation Failure, Battery Failure and Cyber Hacking - A Triple Threat for Pacemaker Patients August 24, 2017. By Anne Wallace.
Washington, DC: Premature insulation failure in recalled St. Jude Medical Riata defibrillator (ICD) leads may be only the tip of the iceberg for heart patients with ICDs, more commonly known as “pacemakers.”
Read [ Insulation Failure, Battery Failure and Cyber Hacking - A Triple Threat for Pacemaker Patients ]

Implantable Defibrillators with Faulty Batteries Lead to Class Action

Implantable Defibrillators with Faulty Batteries Lead to Class Action August 12, 2017. By Brenda Craig.
Toronto, Ontario Thousands of Canadians and American cardiac arrhythmia patients with implantable defibrillators powered by faulty ion batteries and manufactured by St. Jude’s Medical Inc. and St. Jude’s Medical Canada are or will soon be eligible to join class actions suits in Canada and the US.
Read [ Implantable Defibrillators with Faulty Batteries Lead to Class Action ]

Class Action St. Jude Medical Lawsuit Launched in Canada, Seeks $800 Million

Class Action St. Jude Medical Lawsuit Launched in Canada, Seeks $800 Million July 19, 2017. By Gordon Gibb.
Toronto, ON: One of the most recent lawsuits to be filed against St. Jude Medical with regard to faulty batteries associated with Implantable Cardioverter Defibrillators (ICD) has been filed by a woman in Canada. According to the New York Post (05/12/17), plaintiff Shirley Houle is seeking $800 million in damages on behalf of others similarly affected in a proposed class action.
Read [ Class Action St. Jude Medical Lawsuit Launched in Canada, Seeks $800 Million ]

FDA Dresses Down St. Jude Medical over Faulty Lithium Defibrillator Batteries

FDA Dresses Down St. Jude Medical over Faulty Lithium Defibrillator Batteries June 22, 2017. By Gordon Gibb.
Washington, DC: When Chicago’s Abbott Laboratories acquired St. Jude Medical in a $25 billion acquisition this past January, it appears to have inherited a billion-dollars’ worth of headaches that pre-existed before the takeover happened. And now, Abbott is in receipt of a warning letter from the US Food and Drug Administration (FDA) with regard to issues involving battery problems with its St. Jude defibrillators, and security issues with its home monitoring systems.
Read [ FDA Dresses Down St. Jude Medical over Faulty Lithium Defibrillator Batteries ]

US Food and Drug Administration, FDA, St. Jude Medical Inc.

US Food and Drug Administration, FDA, St. Jude Medical Inc. February 12, 2017. By Gordon Gibb.
Washington, DC: The manufacturer of an implantable cardiac device recently caught in the crosshairs of a cybersecurity concern issued from the US Food and Drug Administration (FDA), continues to deal with reports of premature failure of ICD batteries. St. Jude Medical Inc. warned in early October that while the situation, in its estimation is rare, the early failure of batteries in their implanted defibrillators have caused two deaths.
Read [ US Food and Drug Administration, FDA, St. Jude Medical Inc. ]

FDA Warns Cybersecurity Vulnerabilities Identified With St. Jude’s Implantable Cardiac Devices

FDA Warns Cybersecurity Vulnerabilities Identified With St. Jude’s Implantable Cardiac Devices January 9, 2017. By Lucy Campbell.
Santa Clara, CA: Today the US Food and Drug Administration (FDA) issued information and recommendations regarding cybersecurity vulnerabilities for St. Jude Medical's radio frequency (RF)-enabled implantable cardiac devices and Merlin@home Transmitter. The agency, while confirming there is a risk for a breach, has also noted that to date they have not received any reports of patient harm related to these cybersecurity vulnerabilities.
Read [ FDA Warns Cybersecurity Vulnerabilities Identified With St. Jude’s Implantable Cardiac Devices ]

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