Pacemakers are medical devices that require an electrical current to operate. This battery needs to be changed periodically in order to keep the pacemaker working properly. Pacemaker batteries generally last from seven to eight years (some can last as long as ten years), and there are definite risks if the battery ceases to work prematurely. Medtronic pacemakers have experienced premature battery failure in several instances, one of which caused a patient’s death. As a result, the FDA issued a safety warning about several models of Medtronic pacemakers.
Medtronic pacemakers are powered by lithium ion batteries. Pacemakers manufactured by other companies that used this type of battery have previously been the subject of a device recall. Each pacemaker has a capacitor, which is an electronic component that stores electrical energy. This is a ceramic component that is susceptible to cracking in certain rare instances. Here, the Medtronic pacemakers did develop a crack that caused electricity to drain from the battery. This is caused by the fact that that crack can cause a short, which drains the electricity from the battery. This caused the battery to prematurely fail. The battery failure leads to the loss of communication between the pacemaker manufacturer and the device.
The problem for patients when the battery fails is that they have little to warn them of the issue. Instead, they notice it when they begin to experience side effects. Here, when the pacemaker fails, patients can feel severe shortness of breath, lightheadedness, dizziness, chest pain. It is only having their pacemaker examined that they would realize the symptoms are the result of the battery’s failure.
While pacemaker batteries are supposed to last up to eight years, the three adverse event reports that were filed with the FDA indicated that the batteries failed within a year of implantation of the device. In the three incidents that were reported, one of the patients did not experience any harm since the device was not implanted at the time that battery issues were experienced. One of the other patients died since they were dependent on the device. The other patient experienced dizziness, and the device required replacement.
The instances of battery failure, while a definite possibility due to the design of the pacemaker, are still extremely rare. The occurrence rate for this failure is 0.0028%. Nevertheless, as evidenced by a death, the consequences of battery failure can be severe. Those who have this device implanted need to be vigilant for signs that the battery is draining. While there is not yet a recall issued for the device, physicians should check for decreases in battery levels when seeing patients for follow-up visits.
When batteries are nearing depletion, the pacemaker will issue an ERI alert. This means that the pacemaker has less than three months of battery remaining and should be considered to be a medical emergency. However, there is no way of knowing when this alert is approaching. When a pacemaker does reach the stage of the alert, it must be immediately replaced.
Patients should avail themselves of an at-home app that can be used to monitor pacemaker battery life. They should routinely check the remaining battery, and the app will transmit the message to the physician if the battery is running low. This will help avoid the sudden loss of power in the pacemaker. Of course, if any patient has been harmed due to pacemaker failure, they should immediately consult an attorney at The Law Offices of Sadaka Associates to discuss their legal rights.
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