St. Jude Medical, Inc. is a global company that designs and manufactures health management solutions, including heart devices. On October 11, 2016, the company issued a field advisory to physicians, patients and caregivers warning that the company’s Implantable Cardioverter Defibrillator, ICD, and Cardiac Resynchronization Therapy Defibrillator, CRT-D, device batteries may prematurely fail, and a recall of a number of the almost 400,000 devices that have been implanted in patients.
These types of devices are implanted under the skin in the chest area to shock a patient’s irregular or rapid heartbeat into its normal rhythm, or provide pacing for slow beating hearts. The batteries used in the ICD and CRT-D devices at issue are designed to last seven or more years. When a battery gets low, the device vibrates at intervals to let the patient know that they need to see their physician and have it replaced within 90 days. The affected batteries are failing before the time period allowed has expired. According to the Federal Food and Drug Administration, FDA, the failures have resulted in two deaths; one in Europe and one in the United States. Other issues reported include fainting and dizziness.
After 841 of the recalled devices were analyzed by St. Jude Medical, it was found that the problem was a lithium cluster build-up in the batteries. According to Reuters, the batteries that are failing were manufactured prior to May, 2015, when St. Jude Medical added insulation to the devices to reduce the chance of electrical short circuits.
St. Jude Medical has set up a website page that allows patients to find out whether the device they have had implanted is one of the devices that have been recalled. Although this is a recall, St. Jude Medical is not recommending that patients contact their health care provider to have it replaced. Instead, the company is advising patients to consult with their doctor to determine whether replacement would result in a higher risk to the patient’s life than leaving the defective device in place, given the low incidence of deaths. It is also advising patients to immediately contact their physicians when the device sends a vibration indicating that the battery is low. If a physician decides that replacement is preferable, based on the patient’s circumstances, St. Jude Medical will provide a replacement device free of charge.
The main problem with this recall is that, according to the FDA, many patients do not detect the vibration that is designed to alert them when the battery is low. In addition, there is no test or other method to determine the amount of life left in the battery. To counter this problem, St. Jude Medical is advising patients to sign up for its Merlin Patient Care Network. That system can monitor the operation of individual patient devices and send notifications if a problem occurs.