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St. Jude ICD Product Recall

St. Jude Medical Inc., has 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.

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FDA Safety Communication for St. Jude Heart Devices

The US Food and Drug Administration (FDA) has 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.

St. Jude ICD and CRT-D Device Recall

The following St. Jude ICD and CRT-D device models are involved in the recall. The affected models have been manufactured before May, 2015.
  • Fortify
  • Fortify Assura
  • 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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ST JUDE ICD LEGAL ARTICLES AND INTERVIEWS

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

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


READER COMMENTS

Posted by
DONALD BUFKIN
on
My dad just had a St. Jude ICD model CD1357-40Q replaced after 13 months, malfunction of capacitor/battery. have you had any suits on this. They replaced with same model, suppose to be good for about 10 years.

Posted by
Rene
on
My husband had to defibrillator pacemaker put in so he was having issues with finished with blue flashes that would bring them down to ground we went back to Saint Jude and they said everything's fine with in a couple months if he passed away I found out to another lawyer in New York that they had a lawsuit against Saint Jude and they said they couldn't do anything because the product was not me called I found out the product was recalled just do you couple days ago need to find out if the pacemaker defibrillator reader we're default All his medical records even the card for the pacemaker

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