TWIN CITIES, Minn. — Medtronic’s defective pacemaker batteries have caused one person to suffer severe injuries while another person has died. The U.S. Food and Drug Administration, or FDA, said that the batteries used in Medtronic’s pacemakers drain too quickly, thereby causing the pacemaker to malfunction. The Minneapolis/St. Paul Business Journal reported that the FDA issued a warning to patients wearing a pacemaker but not a full recall. Medtronic is a company based in Ireland but has a corporate presence in Fridley, Minnesota.
Medtronic announced that the battery depletion problem happened in only three out of 266,700 in use worldwide. One of the patients died because the battery of the pacemaker depleted, and the pacemaker could not properly function. Additionally, a second person needed to have the pacemaker surgically removed and a working pacemaker inserted after the patient began to feel lightheaded and dizzy. The third pacemaker in issue was never connected to the patient’s heart. The surgeon observed that the pacemaker’s battery ran out of electrical signal. The surgeon swapped the malfunctioning unit out for a working pacemaker.
Medtronic identified the problem in the manufacturing process. The company said that the capacitor cell could suffer from internal cracking while under heat and mechanical stress during the manufacturing process. The capacitor could develop a pathway for leakage. When leakage occurs, the capacitor loses power, and the battery depletes rapidly.
Patients wearing a pacemaker manufactured by Medtronic should pay close attention to the battery power levels. Patients are advised to do nothing unless and until the battery loses power. At that point, a surgeon may need to replace the unit. However, one physician noted that the conservative approach stems from the potential of contracting an infection is higher when having a pacemaker swapped out than encountering a power drain from the battery. Patients with concerns should consult their physician.
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