Approximately 174,000 of St. Jude Medical’s implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators are reportedly slated to get new software updates designed to protect against unwanted device access.
Abbott, which first announced plans to acquire St. Jude Medical in 2016, advised patients to get the new firmware at their next visit to the doctor. The company explained that during the upgrade, a wand will be placed over the patient’s ICD or CRT-D to transfer the information to the device. All told, the upgrade process takes roughly three minutes, according to Abbott.
“The security update provides an additional layer of protection against unauthorized access to your device. It is intended to prevent anyone other than your doctor from changing your device settings. Abbott has had no reports of hacking or unauthorized access to any patient’s implanted device,” the company wrote.
The FDA categorized the firmware updates as Class 2 recalls at the end of June, according to the Star Tribune.
Although implanted medical devices include features like wireless access for remote patient monitoring that appear to render the devices vulnerable to cybersecurity threats, Abbott emphasizes that no such attack has ever been documented.
“As with the previous pacemaker updates, the U.S. Department of Homeland Security reports compromising the security of these devices would be extremely difficult and require a high level of expertise,” the company added.
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