St. Jude Medical (STJ) Issues Field Advisory Related to IDC, CRT-D Devices
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St. Jude Medical (NYSE: STJ) posted the following to its website on Tuesday:
On October 11, we issued a field advisory related to premature battery depletion associated with lithium deposits in a subset of our ICD and CRT-D devices 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. We have consulted extensively with our Medical Advisory Board, other leading experts and regulatory agencies worldwide, and have the following 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 decision is made to replace an affected device based on a patient's circumstances, St. Jude Medical will provide a replacement device at no cost.
None of St. Jude Medical’s pacemakers are affected by this advisory as they are powered by low voltage batteries.
Our highest priority is the safety of patients depending on our life sustaining technology and we are working with regulators and physicians to communicate about this advisory and the resources we are providing to assist with patient management.
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