Medtronic is recalling more than 13,000 Dual Chamber Implantable Pulse Generators, which could experience circuit errors that make the implant stop working.
The FDA announced the Medtronic Implantable Pulse Generator (IPG) recall on February 15, indicating it considers the action a Class I recall, meaning that continued use of the device poses a risk of serious injury or death.
IPGs are implanted cardiac pacemakers, which increase a patient’s heart rate by providing stimulation to the heart. Most patents who use them suffer from bradycardia, a type of slow heart rhythm, or no heart rhythm at all.
According to the FDA’s warning, the IPGs can suffer a software error that can cause the device to stop pacing. The failure can occur at any time and cannot be predicted by a doctor. If pacing stops, patients can experience slow heartbeat, low blood pressure, and other symptoms like light-headedness, fainting, and even death.
The recall affects Dual Chamber Implantable Pulse Generators by Medtronic, Inc. sold under the model names Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron A, E, G, and Q series. The affected devices were manufactured from March 2, 2017 until December 18, 2018 and distributed between March 6, 2017 and January 7, 2019. The recall notice indicates that 13,440 units are affected.
So far, no deaths have been reported in connection with this recall. However, the FDA classified the recall as class I, the most serious type of recall, because the problem can lead to serious injuries and even death if not given proper attention.
Medtronic issued a “Field Corrective Action Notification” letter to doctors who use the devices last month. The letter instructed doctors to program the device to a non-susceptible pacing mode until the software has been updated and corrected.
The letter also provided more programming recommendations and patient risk assessments.
Medtronic says it will also issue “Supplemental Letters” to patients whose devices have shown evidence of a pause in pacing that may be related to a circuit error.
Doctors should return all unused and unopened products affected by the recall to Medtronic. Patients should contact their doctor immediately if they experience any new unexpected symptoms.
Customers with questions can call Medtronic’s Technical Services at 1-800-505-4636.
The FDA requests any side effects linked to the Medtronic Dual Chamber Implantable Pulse Generators be reported to the MedWatch Adverse Event Reporting Program.