In October 2016, we notified physicians and patients that a subset of our ICDs and cardiac resynchronization therapy defibrillators (CRT-D) manufactured between January 2010 and May 2015 could potentially experience premature battery depletion.
On April 16, 2018 we released information about the availability of a planned upgrade to the firmware on a subset of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. This firmware upgrade incorporates two updates to improve performance and strengthen the security of these devices. These updates are part of Abbott’s ongoing commitment to continuously improve patient care.
The first update, called a battery performance alert, gives your device the ability to automatically detect abnormal battery function and notify you directly with a vibrating alert in the event it does. This battery performance alert update is for patients with Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™ and Unify Quadra™ devices manufactured between January 2010 and May 2015.
Please follow the steps below to determine if your ICD or CRT-D is subject to this global medical advisory. Check Now
If you have any further questions about the Battery Performance Alert, please contact our dedicated hotline at 1‐800‐436‐5056 (U.S.).
In October 2016, we notified physicians and patients that a subset of our ICDs and cardiac resynchronization therapy defibrillators (CRT-D) manufactured between January 2010 and May 2015 could potentially experience premature battery depletion. On August 29, 2017, we released a new Battery Performance Alert.
The Battery Performance Alert is a tool designed to provide physicians with an earlier warning of potential premature battery depletion in devices subject to the October 11, 2016, Medical Device Advisory. The Battery Performance Alert uses an algorithm to detect abnormal battery behavior, which will reduce the already low risk of premature battery depletion in affected devices.
The Battery Performance Alert is available for the following devices subject to the October 2016 Medical Device Advisory: Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™, and Unify Quadra™. If you need to check if your device was subject to the October 2016 advisory, please see below.
If you have any further questions about the Battery Performance Alert, please contact our dedicated hotline at 1-800-722-3774 (U.S.).
To improve patient management, we developed a new Battery Performance Alert, which is intended to be used as a tool to provide physicians with earlier warning of premature battery depletion from short circuits due to lithium clusters in devices subject to the October 11, 2016 Medical Device Advisory for premature battery depletion.
The alert uses an algorithm to detect abnormal battery behavior. It is important to note that the potential for premature battery depletion in the affected devices is low.
For patients who use remote monitoring, remote monitoring updates will be automatically applied resulting in regular evaluation of the battery performance of your device. You must ensure your Merlin@home™ transmitter is connected.
For all patients (including those not using remote monitoring) the battery performance of their device will also be evaluated with every in-clinic follow-up visit.
The update will happen automatically. All you need to do is make sure your Merlin@home™ transmitter is connected and that you are sleeping near your transmitter.
All battery advisory patients will have their battery performance evaluated at their next in-office clinic visit.
You should promptly schedule a visit to your physician’s office for an in-person evaluation.
St. Jude Medical announced a global medical device advisory for a subset of our company’s Fortify™, Fortify Assura™, Quadra Assura™, Unify™, Unify Assura™ and Unify Quadra™ implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. This advisory was implemented after an analysis found that some devices manufactured prior to May 23, 2015 contain batteries which may run out of energy earlier than expected. This is termed: “premature battery depletion”.
The likelihood that this will impact your health is low, as the vast majority of devices have not experienced premature battery depletion.
Please follow the steps below to determine if your ICD or CRT-D is subject to this global medical advisory.
Only enter the four digit model number. Do not enter the prefix (CD) or suffix (such as -40, -40QC, -40Q).
To identify your model number and serial number, please locate your patient ID card. Learn more about your patient ID card.
If you cannot locate your patient ID card and your implant was performed in Australia, Canada or the United States, you can request a new patient ID card or update your contact information either:
If your implant was performed somewhere else, Abbott does not retain your patient records, in accordance with local privacy laws. Please contact your physician to obtain the model number and serial number for your device. Your physician should be able to confirm whether your device is subject to the advisory, or you may use this look up tool once you have that information.
You may know that Abbott devices are capable of remote monitoring. This is a proven method of proactively monitoring devices without the need for an in-person office visit. If you do not already utilize remote monitoring for your device, your physician may soon discuss using Merlin@Home™ with you if they feel it is appropriate. Learn more about remote monitoring.
Your device is designed to deliver a vibratory alert to you when the battery is nearing its end of life. The device also delivers a notification to your physician with Merlin@Home or during a doctor visit. Your physician may have helped you experience a test alert to ensure you know what this alert feels like. If you experience a vibratory alert, we recommend that you contact your doctor promptly.
We are advising physicians on the recommended follow-up of devices subject to this advisory. Your doctor will determine the best course of action with you.
If you have any questions, we have also established a toll-free telephone hotline which is available in the U.S. for you to call: 1-866-915-5065
We sincerely apologize for any difficulties this current issue causes you or your caregivers. We take this matter very seriously. Please know that we are available to assist you if you are having problems with your device.
Abbott works closely with our physician partners to ensure patients have the information they need related to our recent global advisory. We regularly update our Frequently Asked Questions to ensure physicians and patients continue to receive helpful information.
Abbott has issued a precautionary global medical device advisory to notify physicians that a subset of our ICD and CRT-D devices may have the potential to experience premature battery depletion (batteries which may run out of energy earlier than expected) associated with lithium deposits.
This advisory applies to a subset of our Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™ and Unify Quadra™ ICD and CRT-D devices manufactured before May 23, 2015.
The likelihood that this will impact your health is low, as the vast majority of devices sold worldwide have not experienced premature battery depletion. Your physician will be able to help you understand how your battery is performing. In addition, your doctor can proactively check the operation of your device for signs of premature battery depletion through remote monitoring using your Merlin@Home system or in person visits. It is also important to know that your devices have built-in safeguards – such as vibratory alerts that would alert you to the need to replace your battery – to help you and your doctor know if your device may be nearing the end of their battery life.
No. It is important to understand that if your device is not experiencing premature battery depletion, replacing your device is NOT recommended by Abbott or our Medical Advisory Board. We are advising physicians on the recommended follow-up of devices subject to this advisory. Your doctor will determine the best course of action for you.
Lithium batteries are powerful and lightweight batteries used to power a wide range of devices. The medical device industry relies on lithium batteries for their ability to deliver energy to life-saving devices that require large amounts of power but that need to remain small in size for patients.
No. This advisory is completely unrelated. Our batteries are designed in a way that they cannot exhibit the types of issues with lithium-ion batteries used in cell phones and tablets. Our batteries are not rechargeable and have safety features that prevent extreme overheating conditions in case a short circuit were to occur as well as an airtight (hermetic) seal around the battery.
When patients implanted with ICDs or CRT-D devices visit their physician, they often have the health of their battery checked to ensure normal operation. Your physician will be able to help you understand how your battery is performing. In addition, using remote monitoring through your Merlin@Home, your doctor can check on the status of your battery (in countries where the service is available).
If your device is reaching the end of its battery life, it is designed to both notify your physician and physically vibrate to make you aware. Your physician may help you test this vibratory alert during your next visit. If your vibratory alert occurs, please contact your physician.
Your device is designed to deliver a vibratory alert to you when the battery is nearing its end of life, meaning that the device itself will gently vibrate. It is a noticeable but gentle vibration.
The device also delivers a notification to your physician with Merlin@Home or during a doctor visit. Your physician may have helped you experience a test alert to ensure you know what this alert feels like. If you experience a vibratory alert, we recommend that you contact your doctor promptly.
We have provided detailed information related to this advisory to your doctor. As each individual patient with a device impacted by this advisory has a unique medical condition, patients are advised to contact their physician for additional information, including any specific questions you may have related to this advisory.
No, this advisory is limited to a subset of our high voltage devices. Low voltage devices, such as pacemakers, are not impacted.
No. All devices impacted by this advisory have been removed from hospital inventories and devices manufactured after May 23, 2015 are not impacted by this advisory.
You should discuss enrollment with your doctor and if the system is appropriate for you. For devices impacted by this advisory, Abbott will provide access to our Merlin remote monitoring network and the Merlin@home unit at no cost. Learn more about remote monitoring.
If the decision is made by a physician to replace a patient’s affected device due to premature battery depletion or for unique clinical considerations within 180 days of the advisory, Abbott will provide a credit for a replacement device. Your physician’s office can work with our Warranty Department by emailing SYWarrantydept@sjm.com or calling 1-800-423-5611.
Yes, if a device is explanted and the conditions of our warranty are met, Abbott will provide payment to patients in the U.S. for UMEs related to the replacement procedure up to $2,500. Contact our Warranty Department at SYWarrantydept@sjm.com to receive support with this process.
Yes, Abbott will also provide payment to U.S. patients for one-time office visits needed to assess Advisory related concerns. In such cases, Abbott will cover Unreimbursed Medical Expenses (such as medical co-pays) up to a one-time maximum benefit of $150. To secure payment, patients should provide Abbott their completed patient request form (28kb pdf), or a similar provider request form (29kb pdf), a copy of their final bill and their Explanation of Benefits (EOB) form from their insurance provider. Only one completed form is required, and it can come from either the patient or physician. Learn more about this process (87kb pdf).
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