February 20, 2019 — Medtronic is recalling its dual chamber implantable pulse generators (IPGs) due to the possibility of a software error that can result in a lack of pacing. 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.
Medtronic’s dual chamber IPGs are implanted cardiac pacemakers used to provide stimulation to increase heart rate in patients with a slow heart rhythm (bradycardia) or no heart rhythm. The pulse generator is the small implanted unit containing the battery and other electronic parts. The pulse generator must be used with insulated electrode wires called leads. These devices are designed to be used in addition to routine clinical monitoring by a healthcare professional.
The recall impacts Medtronic’s Adapta, Versa, Sensia, Relia, Attesta, Sphera and Vitatron A, E, G and Q series IPGs. All affected products were manufactured between March 2, 2017, and Dec. 18, 2018; they were distributed between March 6, 2017, and Jan. 7, 2019. A total of 13,440 devices have been recalled in the U.S.
Beginning Jan. 17, 2019, Medtronic’s field representatives have hand-delivered “Field Corrective Action Notification” letters to implanting and follow-up physicians.
For healthcare providers:
Medtronic recommends programming to a non-susceptible pacing mode as the primary mitigation for patients implanted with an affected device until the software update has been installed;
Additional patient risk assessment and programming recommendations are included in Medtronic’s advisory letter;
In addition to the field correction notification, Medtronic’s field representatives will:
Hand-deliver an additional “Supplemental Letter” alongside an “Urgent Medical Device Recall” letter to physicians with patients whose devices have shown evidence of a pacing pause that may be related to this circuit error;
Request physicians return all unused and unopened affected product to Medtronic for replacement;
Confirm notifications are received by implanting or follow-up physicians using Medtronic’s electronic tracking system in conjunction with confirmation via a paper form; and
Conduct effectiveness checks to ensure that all identified implanting or follow-up physicians and risk managers have been notified or proof of at least three attempts to notify them is obtained.
The letter recommends that patients remaining in a susceptible mode should seek immediate medical attention if experiencing any new or unexpected symptoms consistent with a pause in pacing.
Customers who have questions or need additional information regarding this recall may contact Medtronic’s Technical Services at 1-800-505-4636.
Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Healthcare professionals employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
For more information: www.medtronic.com