Patients with Medtronic Defibrillators already know firsthand how defective these devices can be. In addition to previously known issues, the U.S. Food and Drug Administration (FDA) issued another warning for patients: these devices could be vulnerable to hacking. In a recent warning letter, the FDA cautioned patients that a software update must be made to protect the device from cybersecurity vulnerabilities.
The FDA’s latest warning refers to Medtronic CareLink and CareLink Encore Programmers (models 2090 and 29901). These devices allow doctors to obtain device performance data, including checking battery status, adjusting device settings, and reprogramming settings. After reviewing information related to cybersecurity vulnerabilities, the FDA determined the devices have inherent vulnerabilities that could allow unauthorized users to change their functionality. Medtronic received FDA approval for a software update that will help protect the devices from cybersecurity threats, but these troubled devices are far from fixed.
Earlier this year, the FDA announced a nationwide recall of certain Medtronic defibrillators after discovering some of the devices weren’t working properly. There were reports of the devices delivering unnecessary shocks that needlessly shocked implanted consumers, quickly depleting the battery, and instances where the device failed to provide life-saving shocks when needed.
A History With Defective Devices
Medtronic has a long history with defective medical devices. In 2010, the company had to recall thousands of defibrillators and eventually agreed to pay $268 million to patients harmed by the devices. Patients need to know the medical devices being implanted inside them have been thoroughly tested for all defects. If there are any risks associated with these devices, patients have a right to know of them before choosing to be implanted. Medtronic has repeatedly put patients at risk with their defective devices and patients deserve to hold them accountable for the resulting injuries.
Medtronic Defibrillator Lawyer
If you or someone you love suffered an injury from a Medtronic defibrillator, you have legal options. Contact a Medtronic defibrillator lawyer at Dax F. Garza, P.C. today for a free consultation to discuss your case. We work on a contingency fee basis, meaning our consultations are free, there is no upfront cost for working with us, and you won’t owe us anything unless we help you recover compensation.