St. Jude Medical Warns of Premature Battery Depletion in Implantable Defibrillators
If the physician decides to replace an affected device based on a patient's circumstances, St. Jude Medical will provide a replacement device at no cost; the company's statement said that none of its pacemakers are affected by this advisory because they are powered by low-voltage batteries.
St. Jude Medical, a global medical device company, issued a field advisory on Oct. 11 that is related to premature battery depletion associated with lithium deposits in a subset of the company's ICD and CRT-D implantable defibrillators manufactured before May 23, 2015. "While it is a rare occurrence (0.21%), we want to ensure we are providing the information physicians need to best care for their patients," the company's statement said, adding that, after consulting with the company's Medical Advisory Board, other leading experts, and regulatory agencies worldwide, it has these recommendations for physicians and patients:
- "We have asked physicians to contact their patients with information about this advisory. Device replacement is not recommended unless the physician determines otherwise.
- "Patients can learn if their device is included in the advisory by visiting a dedicated webpage: www.sjm.com/batteryadvisory.
- "Our devices are designed to provide a vibratory alert when the battery is nearing depletion. Patients should always contact their physician immediately when they experience the vibratory alert.
- "Premature battery depletion can be detected during doctor office visits and through remote monitoring. We recommend that patients enroll in Merlin.net remote monitoring service in countries where it is available. This service notifies a physician when the device's battery is nearing depletion. Patients with affected devices can discuss enrollment with their physician, and St. Jude Medical will provide the service at no cost."
If the physician decides to replace an affected device based on a patient's circumstances, St. Jude Medical will provide a replacement device at no cost; the company's statement said that none of its pacemakers are affected by this advisory because they are powered by low-voltage batteries.