St. Jude ICD Defibrillator Recall Lawsuit

Attorneys are investigating possible ICD and CRT-D defibrillator lawsuits resulting from the devices possibly short-circuiting and causing harm to patients. St. Jude Medical Inc., issued a recall of some of its Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) implanted in about 400,000 people. The recall was prompted by the reports of two patient deaths.

As a follow up to the St. Jude ICD and CRT-D defibrillator recall and the FDA safety communication, the FDA sent St. Jude Medical, Inc. a warning letter on April 12, 2017. The letter states that St. Jude officials had systematically underestimated the true risk to patients by basing evaluations of battery failures only on "confirmed" cases of failure--rather than including cases in which the battery had shorted.

Given the severity of injuries reported, allegedly due to St. Jude ICD or CRT-D defibrillator failure, attorneys are now investigating victims' claims for possible defibrillator injury lawsuits.
  The US Food and Drug Administration (FDA) issued a Safety Communication regarding the devices and St. Jude Medical’s advisory on ICD and CRT-D batteries that may fail earlier than expected. They are warning patients with these devices to respond immediately to Elective Replacement Indicator (ERI) alerts. Due to problems with these batteries, patients do not have the normal 3-month lead time for device replacement. Some batteries have run out within 24 hours of the patient receiving an ERI alert.

The implanted defibrillators (ICDs and CRT-Ds) are powered by lithium-based batteries. Deposits of lithium, known as “lithium clusters,” can form within the battery and create abnormal electrical connections leading to rapid battery failure.

St. Jude Medical has reported that in some cases, full battery drainage can occur within a day to a few weeks after the patient receives an ERI alert. If the battery runs out, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death. The patients most at risk are those with a high likelihood of requiring life-saving shocks and those who are pacemaker dependent.
  The following St. Jude ICD and CRT-D device models are involved in the October, 2016 FDA Class 1 Recall The affected models have been manufactured before May, 2015.

• Fortify VR
• Fortify ST VR
• Fortify Assura VR
• Fortify Assura ST VR
• Fortify DR
• Fortify ST DR
• Fortify Assura DR
• Fortify Assura ST DR
• Quadra Assura
• Quadra Assura MP
• Unify
• Unify Asssura
• Unify Quadra

To date, of the 398,740 affected devices sold worldwide, 841 were returned for analysis due to premature battery depletion caused by lithium clusters.

Two deaths (1 in the U.S.), have been associated with devices that could not provide needed shock therapy due to premature battery depletion.

10 patients (9 in the U.S.), have reported fainting from devices that could not provide needed pacing therapy due to premature battery depletion.

37 patients (30 in the U.S.), have reported dizziness from devices that could not provide needed pacing therapy due to premature battery depletion.

Battery depletion may not always be reported to the manufacturer, therefore the true number of devices with premature battery depletion due to lithium clusters is not known. At this time, 349,852 affected devices remain actively implanted worldwide.

ICDs and CRT-Ds are both implanted under the skin in the upper chest area with connecting insulated wires called “leads” that go into the heart. Patients need an ICD or CRT-D if their heart beat is too slow (bradycardia), too fast (tachycardia), or needs coordination to treat heart failure.
 

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Last updated on Mar-18-20