Over 13,000 Medtronic implantable pulse generator (IPG) units have been recalled due to a software glitch that poses a health risk to patients with the implantable pacemakers. The Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron A, E, G, and Q series models manufactured between March 2017 and December 2018 may be affected by the software error.
The Medtronic IPGs are used to treat bradycardia (low heart rhythm) and to restart a stopped heart. The implanted units emit an automatic electronic stimulus to regulate heart rhythms or restart the heart. The software problems in the circuit boards can prevent proper functioning of the device which can lead to slow heart rhythms, low blood pressure, light headedness, fainting, and even death to patients.
Field Corrective Action Notification
In January, Medtronic field representatives began hand delivering letters to doctors who surgically implant the pacemakers and those that monitor patients using the defective units. The Field Corrective Action Notification letters specify preventive and corrective actions to take with patients currently using the implantable devices.
Healthcare professionals, patients, and caregivers of those with Medtronic implantable pacemakers are advised to follow the guidelines listed below to prevent serious complications:
- Program units to non-susceptible pacing modes until a software update is available or the pacemaker can be removed.
- Patients who cannot tolerate the non-susceptible pacing and have no ventricular escape rhythm or risk of symptomatic pause should continue regular clinical monitoring until the device can be replaced or reprogrammed.
Patient Risk from Recalled Medtronic Implantable Pacemaker
Medtronic has released a statement concerning the voluntary recall of their IPG devices to inform patients of the risks involved with the defective product. As of January 4, 2019, four reports of problems associated with a malfunctioning pacemaker were reported. In two of these incidents, patients experienced a pause in their pacing therapy. The problems reported involved three devices from a reported inventory of close to 200,000 units sold in the United States. No deaths related to the recalled devices have been reported.
Medtronic reported that the software error occurred when they made a change in the design of the integrated circuit board in units sold between March 2017 and January 2019. The company is working to develop an update to the software to correct the problem which they expect to submit to the Food and Drug Administration for approval before the end of 2019. Once approval is given, Medtronic plans to notify healthcare providers and patients of the correction and begin replacing recalled implanted devices or performing software updates.
New Brunswick Product Liability Lawyers at the Law Offices of Harold J. Gerr Represent Victims Injured by Defective and Dangerous Products
If you or a loved one has been injured by a defective medical device, you may be entitled to compensation. Call the New Brunswick product liability lawyers at the Law Offices of Harold J. Gerr at 877-249-4600, or 732-249-4600, or contact us online to schedule a consultation today. Our Highland Park, New Jersey offices serve clients in New Brunswick, Somerset, Piscataway, Edison, South River, Sayreville, Metuchen, East Brunswick, South Plainfield, Fords, Middlesex, Old Bridge, Iselin, Bound Brook, Perth Amboy, and Colonia.