Global Medical Advisory Concerning Subset of ICD and CRT-D Devices
What you need to know
St. Jude Medical recently 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.
- Input your device’s model number and serial number, as instructed below, noting both are required.
- 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.
- 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.
To identify your model number and serial number, please locate your device ID card.
Learn more about your device ID card.
If you cannot locate your device ID card and your implant was performed in Australia, Canada or the United States, you can request a new device 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, St. Jude Medical 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
- At-Home Monitoring - You may know that St. Jude Medical 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.
- 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.
- It is important for you to understand that if your device is not experiencing premature battery depletion, replacing your device is NOT recommended by St. Jude Medical 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 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.
Frequently Asked Questions for Patients
St. Jude Medical 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?
St. Jude Medical 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 St. Jude Medical 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 a St. Jude Medical 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 a St. Jude Medical 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 St. Jude Medical 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, St. Jude Medical will provide access to our Merlin remote monitoring network and the Merlin@home unit at no cost. Learn more about remote monitoring.
Will St. Jude Medical provide a replacement device if my physician determines a new device to be the best option for me?
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, St. Jude Medical 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.
If I receive a replacement device, will St. Jude Medical cover Unreimbursed Medical Expenses (UME’s) related to that procedure?
Yes, if a device is explanted and the conditions of our warranty are met, St. Jude Medical will provide payment to patients in the U.S. for UME’s related to the replacement procedure up to $2,500. Contact our Warranty Department at SYWarrantydept@sjm.com to receive support with this process.
Will St. Jude Medical provide financial support for my doctor visit to discuss whether my device is impacted by this advisory?
Yes, St. Jude Medical will also provide payment to U.S. patients for one-time office visits needed to assess Advisory related concerns. In such cases, St. Jude Medical 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 St. Jude Medical their completed patient request form (pdf), or a similar provider request form (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 (pdf).