FDA warns of a battery-depletion problem in some pacemakers

May 14, 2019 | Crandall & Pera Law
FDA warns of a battery-depletion problem in some pacemakers

Early May, the U.S. Food and Drug Administration (FDA) released a warning about a battery-depletion problem in some Medtronic pacemakers. Although no recall was issued, the FDA warns patients who use certain models of Medtronic pacemakers to be watchful for signs of a low battery. How are some pacemakers malfunctioning? The batteries in some Medtronic pacemakers have completely drained without any warning to the patient or health care provider. This premature battery depletion occurred because a crack formed in the pacemaker’s capacitor, which stores energy and is one of the main electronic components of the pacemaker. A crack in the capacitor can cause a short, which then leads to the battery draining sooner than expected. The battery depletion can occur over several days or weeks. Without a functioning battery, a pacemaker will not be able to shock a heart back into rhythm. At least three people have died because of this malfunction, according to the FDA. All three reported incidents occurred within the first nine months following the implant of the pacemaker. What should do if I have a Medtronic pacemaker? Potentially affected models of Medtronic pacemakers include some Azure, Astra, Percepta, Serena and Solara models. Having a potentially affected model does not necessarily mean that you need to replace your pacemaker. However, if you have an at-risk model of pacemaker, you should take several actions to prevent a potentially dangerous situation from occurring. If you think your pacemaker could is at risk of being affected, it is important to talk with your doctor. Your doctor may be able to offer you information and advice specific to your situation. Also, verify that your home monitoring transmissions are working properly at the prescribed times. These transmissions help your doctor make appropriate decisions for your situation, including decisions that could be impacted by your pacemaker’s battery level. You can also monitor your pacemaker’s battery yourself with the MyCareLink Heart app. Checking this app periodically can help you quickly identify if there are any significant changes in your pacemaker’s battery level. What signs may indicate that my pacemaker is not working properly? You should seek immediate medical help if you notice signs that your pacemaker has a low or drained battery. Signs that your pacemaker’s battery may be low or drained include feeling:

  • Lightheaded
  • Dizzy
  • Chest pain
  • Shortness of breath
If you have been harmed because of a faulty pacemaker, it may be appropriate to seek justice. You may be able to receive compensation for your medical expenses and other costs associated with your injuries.