Devices

FDA Alert on Magnetic Interference With Defibrillators

FDA is alerting healthcare professionals about magnetic interference between breast tissue expanders with magnetic injection ports and either implantable cardioverter-defibrillators (ICDs) or pacemakers in patients. The agency says it has analyzed peer-reviewed literature, device labeling, adverse event medical device reports, and information from ICD manufacturers, health care organizations, and professional societies. “At this time, the FDA believes that there is a very small population at risk, as it is generally uncommon for patients with an ICD or pacemaker to have breast reconstruction,” the safety alert says.

In patients with a magnetic-port breast tissue expander who also have an ICD or pacemaker, the magnetic port can come close enough to the cardiac device to cause magnetic interference, according to the alert. “This interference causes the ICD or pacemaker to enter ‘magnet mode,’” it says “ICDs in magnet mode will not deliver life-saving shocks or anti-tachycardia pacing therapy, which can be life-threatening to the patient if a dangerous abnormal heart rhythm were to occur. Patients might hear an electronic tone indicating that the device is entering magnet mode, depending on the ICD make and model. When a pacemaker enters magnet mode, the device continuously paces without sensing the patient’s own heart rhythm, which can result in symptoms (such as irregular heartbeats), abnormal heart rhythms, or rarely, more serious patient harm. The likelihood of magnetic interference (entering magnet mode) varies depending on the type of implant and the proximity of the breast tissue expander to the ICD or pacemaker.”

The alert recommends, whenever possible, to avoid implanting a magnetic-port breast tissue expander in a patient with a pacemaker or an ICD.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome