Medtronic is recalling specific models of its dual-chamber implantable pulse generators used to manage patients with bradycardia because of the possibility of a software error than can result in a lack of pacing, the US Food and Drug Administration (FDA) has announced.
The FDA is categorizing the recall as class I, the most serious type. The recall affects 13,440 devices in the United States distributed between March 6, 2017 and January 7, 2019. The affected models are Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron A, E, G, and Q series.
"Patients and physicians cannot predict whether and when this software error might occur. A lack of pacing could result in patients experiencing slow heart beating, low blood pressure, and symptoms such as light headedness, fainting, and even death," the FDA notice said.
Up to January 4, 2019, there were four reported instances in two patients "where a pause in pacing therapy was clinically apparent due to this circuit error," the company says in an advisory letter. There were no deaths.
"If this error occurs, the device will be unable to provide pacing until a ventricular-sensed event (VS) is detected," the advisory says. "Once a VS is detected, normal pacing functionality is restored immediately. If a VS is not detected, the device will withhold both atrial and ventricular pacing. In addition, until a VS is detected, the device will be unable to initiate a session with a programmer, initiate a session with a CareLink™ remote monitor, or respond to a magnet."
Medtronic began hand delivering "Field Corrective Action Notification" letters to physicians beginning January 17 and estimates it will have a software update submitted to regulatory agencies by the second half of 2019.
Medtronic recommends physicians program affected pacemakers to a nonsusceptible pacing mode to mitigate the issue until the software update can be installed. Additional patient risk-assessment and programming recommendations are included in Medtronic's advisory letter.
The root cause of this issue is related to a design change to an integrated circuit in a subset of devices that were distributed between March 10, 2017 and January 7, 2019, according to the company.
The FDA recall notification letter is available online. Medtronic is requesting that all unused and unopened affected product be returned for replacement.
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Cite this: Medtronic Recalls More Than 13,000 Pacemakers for Possible Circuit Error - Medscape - Feb 19, 2019.