According to a new public warning from the FDA, certain leadless pacemakers made by Medtronic have a defect that may cause them to poke holes in the heart resulting in life-threatening complications.
The Food and Drug Administration (FDA) recently posted a new warning regarding a potentially fatal defect in the Medtronic Micra leadless pacemaker devices. The November 17 warning advises doctors about new findings which show that patients with the Medtronic leadless pacemaker implanted have displayed a significantly higher risk of cardiac perforation and potentially deadly complications.
Transvenous vs. Leadless Pacemakers
Pacemakers are small medical implant devices that emit electrical impulse signals which help maintain a normal heart rhythm for people with cardiac problems. Pacemakers are widely used to treat individuals who are at risk of heart failure because they help the heart to distribute blood and oxygen throughout the body.
Normal transvenous pacemakers have small wire leads which attach the pacemaker to an implantable cardiac defibrillator (ICD). These wire leads are usually run through a major artery directly into the heart. Once inside the heart, electrodes on the leads monitor heart rhythm so that the pacemaker can correct irregularities.
The Medtronic Micra pacemaker is part of a newer generation of pacemaker devices that are “leadless.” Leadless pacemakers were first approved for use in 2016 and have been very widely utilized since then. Their primary advantage is that they are small and do not have wire leads so no surgical pocket in the chest or wire connections are required.
Problems with Medtronic Leadless Pacemakers
Although the new leadless pacemakers were originally believed to be a safer, better alternative, the new warning from the FDA indicates that they may actually be putting patients at higher risk for certain dangerous complications. Results from clinical studies indicate that the leadless devices carry a higher risk of perforation, cardiac tamponade or death, than with traditional pacemakers.
Overall, the risk of cardiac perforation with leadless devices is rare, occurring in only 1% of implant patients. However, in the 1% of cases where the complication does arise it can be very dangerous. Cardiac perforation may lead to serious complications such as fluid build-up around the heart and emergency open surgical repair, all which can be fatal.
Medtronic is currently working with the FDA to evaluate cases where the cardiac perforation event has occurred following the implantation of a Micra leadless pacemaker. The hope is that this review will identify contributing factors and potential mitigation measures. Medtronic will also be reviewing the product labeling and manual for the Micra to minimize the risks of cardiac perforation during implant.
The FDA is not advising doctors to stop using leadless pacemakers. Rather, doctors are asked to review the risks and benefits of available pacemaker options with patients and advise that cardiac perforation is a rare complication that may be higher with leadless pacemakers vs. traditional transvenous devices.
Other Problems at Medtronic
The recent warning about the Micra leadless pacemaker is the latest issue facing Medtronic over its cardiac implant medical devices. Back in June, Medtronic pulled its Heartware HDAV implant device off the market after numerous reports of pump restart failure in patients. This defect in the Heartware pump resulted in the death of over 3,000 implant patients before Medtronic announced the emergency recall.
Medtronic also had major problems with defects in its MiniMed Insulin Pump. A defective retainer ring in the pumps can cause the vital insulin cartridge to become disconnected from the pump’s reservoir. This can quickly trigger hypoglycemia or hyperglycemia causing very serious injuries or in some cases death.
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If you have been injured by a defective pacemaker or other medical implants, contact our medical device lawyers today for a free consultation.