After two deaths in Europe were linked to possible premature battery depletion in its implanted heart devices, St. Jude Medical Inc. announced on Tuesday (September 11, 2016) that it would be recalling some of the devices.
The company issued a letter to physicians and other medical providers explaining that potential battery depletion can happen among an estimate of 398,740 St. Jude cardioverter defibrillators (ICDs) around the world. These devices are designed to shock a severely racing heartbeat back to its regular rhythm. They all contain batteries which were manufactured before May 23, 2015, back when St. Jude included insulation to reduce the likelihood of experiencing a short circuit.
So far, 841 devices were returned to the company for a thorough assessment because of the battery issue, which has been traced to a build-up of lithium clusters within the batteries. Jeff Fecho, St. Jude’s vice president of quality control, stated in the advisory to doctors that depletion of power can instantaneously render the heart devices incapable of delivering doses of needed electricity.
Two deaths have been associated with premature battery depletion. One of the patients died after his device alerted him, but a few days prior to the planned replacement.
The devices were introduced to the market in 2010 and are designed to have a lifespan of seven years or longer, up until the batteries are depleted. Once power is diminished, the device is supposed to vibrate at regular intervals as a signal to patients to get a replacement within 90 days.
The letter said issues with the lithium batteries were rare. The patients could identify the problems at home by using tools for monitoring battery levels. The FDA says that patients should seek immediate medical attention as soon as they receive a low-battery alert from the monitoring devices.
Injured Due to a Defective Medical Devices?
If you have experienced a serious injury or the wrongful death of a loved one in Kansas City, MO, Bertram & Graf, L.L.C. is dedicated to helping you recover the compensation you deserve. We have an exceptional history of success.
Our experienced legal team has a comprehensive understanding of state and federal laws to help you navigate through the potential complexities of your product liability claim. We can investigate the medical device defect and collect crucial evidence necessary to develop a vigorous and personalized legal strategy.
Do not hesitate to contact our firm if you have experienced injuries using St. Jude’s implantable cardioverter defibrillators.