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APRIL 2018 BATTERY PERFORMANCE ALERT UPDATE FOR A SUBSET OF ICD AND CRT-D DEVICES

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 (BPA), 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 BPA 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.

IS YOUR DEVICE SUBJECT TO THE BATTERY PERFORMANCE ALERT UPDATE?

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 +46 8 474 4147 or 1‐800‐436‐5056 (U.S.).

AUGUST 2017 BATTERY PERFORMANCE ALERT UPDATE FOR SUBSET OF ICD AND CRT-D DEVICES

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. It was recently approved by the U.S. Food and Drug Administration, and we plan to make the update available in your country once it is approved by the appropriate regulators.

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 +46 8 474 4147 or 1-800-722-3774.

FREQUENTLY ASKED QUESTIONS ON THE BATTERY PERFORMANCE ALERT

WHAT IS THE PURPOSE OF THE BATTERY PERFORMANCE ALERT?

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.

HOW WILL THE BATTERY PERFORMANCE ALERT UPDATE HAPPEN?

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.

WHAT DO I HAVE TO DO TO RECEIVE THE BATTERY PERFORMANCE UPDATE?

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.

WHAT SHOULD I DO IF MY PHYSICIAN NOTIFIES ME THAT THE BATTERY PERFORMANCE ALERT HAS BEEN TRIGGERED?

You should promptly schedule a visit to your physician’s office for an in-person evaluation.

OCTOBER 2016 GLOBAL MEDICAL ADVISORY CONCERNING SUBSET OF ICD AND CRT-D DEVICES

WHAT YOU NEED TO KNOW

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.

IS YOUR DEVICE SUBJECT TO THIS ADVISORY?

Please follow the steps below to determine if your ICD or CRT-D is subject to this global medical advisory.

  1. Input your device’s model number and serial number, as instructed below, noting both are required.
  2. If your device is subject to this advisory, patients are advised to contact their physician for additional information, including any specific questions you may have related to this advisory.
  3. If your device is not subject to this advisory, you do not need to take any further action related to this advisory; your device is not impacted by this advisory.

 

 

CHECK YOUR DEVICE

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.

a 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:

  • Through our online form OR
  • Australia: Toll-free number: +61-1800-839-259
  • Canada: Toll-free number: +1-888-276-4170
  • United States: Toll-free number: +1-800-550-1648 or +1-800-777-2237 ext. 2183
    • Hours 6 a.m. to 5 p.m. (Pacific Time), Monday through Friday
    • 24-hour Answering service: +1-800-722-3423

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.

IF YOUR DEVICE IS SUBJECT TO THE ADVISORY, HERE IS WHAT YOU NEED TO DO

1. At-Home Monitoring - 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.

2. Vibratory Alert - 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. 

3. It is important for you 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 with you.

If you have any questions, we have also established a toll-free telephone hotline for you at: +46 8 474 4147 or 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.

FREQUENTLY ASKED QUESTIONS FOR PATIENTS

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.

WHAT IS THE ISSUE?

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.

HOW DO I KNOW IF MY DEVICE IS SUBJECT TO THIS ADVISORY?

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.

IF MY DEVICE IS INCLUDED IN THE ADVISORY, WHAT IS THE LIKELIHOOD THAT MY DEVICE WILL EXPERIENCE PREMATURE BATTERY DEPLETION?

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.

IS IT RECOMMENDED THAT MY DEVICE BE REPLACED BECAUSE OF THIS ADVISORY?

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.

WHAT IS A LITHIUM BATTERY?

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.

I HAVE HEARD INFORMATION RECENTLY ABOUT PRODUCT RECALLS DUE TO LITHIUM BATTERY PROBLEMS IN MOBILE PHONES AND TABLETS. ARE YOUR LITHIUM BATTERIES THE SAME AS THOSE BATTERIES?

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.

HOW CAN I TELL IF MY DEVICE IS EXPERIENCING PREMATURE BATTERY DEPLETION?

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.

WHAT IS A VIBRATORY ALERT AND WHAT DOES IT FEEL LIKE?

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.

MY SERIAL NUMBER APPEARS TO BE IMPACTED BY THIS ADVISORY, BUT MY PHYSICIAN HAS NOT CONTACTED ME. WHAT SHOULD I DO?

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.

I HAVE AN ABBOTT PACEMAKER. SHOULD I BE CONCERNED ABOUT THIS ADVISORY?

No, this advisory is limited to a subset of our high voltage devices. Low voltage devices, such as pacemakers, are not impacted.

I AM SCHEDULED TO RECEIVE AN ABBOTT ICD OR CRT-D DEVICE. SHOULD I BE CONCERNED?

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.

I AM INTERESTED IN REMOTE MONITORING. WILL ABBOTT PROVIDE ME THIS SERVICE AT NO COST?

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.

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