WASHINGTON, D.C. — The U.S. Food and Drug Administration produced evidence to suggest that certain pacemaker batteries could die without warning according to Medtruth.com. The FDA specifically called out the medical device manufacturer Medtronic because the company’s implantable pacemakers and cardiac resynchronization therapy pacemakers’ batteries would drain without warning and thereby rendering the life-saving device inoperable. The FDA received no fewer than three complaints from patients whose pacemaker batteries drained far in advance of the scheduled date for replacement. One person died when his pacemaker did not work owing to a drained battery, and a second person required emergent medical attention for the same reason.
Medtronic designed its pacemakers’ batteries to last for at least seven and one-half years, but they could last as long as 15 years. Similarly, Medtronic’s resynchronization therapy pacemakers’ batteries should last for six to ten years. However, cracks in the capacitors of the devices result in a premature drain of the battery charge. Consequently, the batteries must be replaced well ahead of schedule.
The danger with this malfunction lies in the design of the life-saving devices. They are implanted in the body of the patient and, therefore checking the battery power is difficult. Patients who have a Medtronic pacemaker must pay close attention to worsening symptoms such as fatigue, lightheadedness, shortness of breath, and other signs of heart failure because these symptoms indicate that the device is not working as designed, if at all. Signs of these symptoms must be reported to a physician immediately.
In all, 132,000 potentially defective heart devices are on the market. The defective devices include Medtronic models such as Azure, Astra, Percepta, Serena, and Solara. The FDA says that replacement is not indicated in every case. The FDA cautions patients that urgent medical care is necessary, and replacement of the device is required if the device issues an Elective Replacement Interval warning. Also, patients must follow their doctors’ recommendations for transmitting data through the monitors that accompany the pacemakers.
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