The FDA recently announced that medical device manufacturer Medtronic has issued an implantable cardioverter defibrillator recall for 48 of its resynchronization defibrillators. The reason for the recall is the device’s inability to deliver the correct level of voltage to effectively pace a person’s heartbeat. According to the American Heart Association, these devices are made to prevent deaths caused by cardiac arrest.
The two types of devices manufactured by Medtronic involved with the recall are the Cardiac Resynchronization Therapy Defibrillator (CRT-D) as well as an Implantable Cardioverter Defibrillator (ICD). Each one of these is designed to deliver a safe shock to a slow or speed up a heart rhythm. Their electrical shocks are known as pacing and designed to end a heart rhythm that is not normal. Some of these devices are implanted under an individual’s skin. They are placed in the upper chest area of a person and have connecting insulated wires. These wires are known as leads and are placed inside a person’s heart. An individual will use one of these devices if their heartbeat is too fast or too slow. They are also used if coordination is necessary to treat a person’s heart failure.
An urgent medical device recall notice was given to affected individuals and their caregivers on January 22, 2018. According to the FDA, the recall of Medtronic resynchronization defibrillators was initiated because a defect was discovered. This defect could cause the gas mixture inside the device to be out of specification. When this happens, it will prevent the resynchronization defibrillators from providing the necessary electrical shock. These defective devices were manufactured between July 2013 and August 2017. The serial numbers of these resynchronization defibrillators are listed on the recall notice at the FDA’s website.
Any person who is a patient using one of the recalled Medtronic resynchronization defibrillators will be affected by this recall. It will also affect caregivers who have people in their care using one of these devices. Any professional healthcare provider using them to treat their patients are affected by the implantable cardioverter defibrillator recall. The FDA recommends affected people who are currently using the defective devices consider a prophylactic device replacement. Medtronic representatives should be contacted about the terms and conditions associated with the device’s warranties. All recall notices should be carefully reviewed.
Medtronic vice president Tim Samsel has stated they are not able to identify which one of the many devices they manufacture could stop working or when they may stop working. The company is also unable to determine the number of high-voltage charges that may happen before a potential failure occurs. Tests were conducted on a small sample of the devices. Failures occurred with over 22 percent of them. Over seven percent of the devices stopped working within the first two initial high-voltage charges. These failures are what prompted the FDA to issue a recall status that denoted a serious death or injury risk with these defibrillators.
Manufacturing Process Update
A spokesperson for Medtronic has stated the failures of their resynchronization defibrillators have not caused the death of any person. There has been one confirmed failure of a device that lost its functionality. This did result in the external defibrillation of a person to rescue them. The company’s spokesperson has also stated their manufacturing process has been updated. This was done to prevent specific manufacturing issues associated with the recall from happening again.
Medtronic is one of the largest medical device manufacturers in the world. According to research conducted by the National Institutes of Health (NIH), the number of advisories and recalls for these kinds of devices have grown during the previous three decades. The specific rates of complications associated with them is currently unknown.
Learn more about Medical Device Recalls.