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The Food and Drug Administration (FDA) has issued a recall of nearly 62,000 pacemakers that were distributed between April 2015 and February 2019 after it was discovered that moisture could get inside the device causing an electrical short. The agency said there have been 135 complaints, 135 injuries but no deaths related to the recall of Assurity and Endurity implantable pacemakers.
The devices, made by Abbott, work to detect when the heart is beating too slowly, and then send signals to the brain to make it beat at the correct pace. If there is an electrical short in the device, it could spur wrong information, impact battery life, lose pacing function or require replacement.
“If the device is unable to deliver pacing, patients may experience slow or irregular heartbeat, fainting, shortness of breath, tiredness, dizziness or discomfort,” the FDA said, on its recall notice. “Additionally, shorter battery life and device life may lead to an additional pacemaker replacement procedure sooner than expected. Finally, if the system does not relay accurate information via telemetry, medical providers may not know to provide treatment.”
Abbott first notified patients of the issue in March, and said there was no recommendation to replace the device if there was no evidence of an issue due to low incident rate. It did recommend replacement for devices that experienced sudden battery depletions or end of service warnings, or in patients who experienced “a clinical impact.”
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