Abbott issues second round of updates on St. Jude pacers

The pacemaker cybersecurity update is the second released by Abbott this year

The pacemaker cybersecurity update is the second released by Abbott this year

Abbott says that new pacemakers made as of 28 August will come pre-patched with the update, and both the company and FDA say that already-implanted devices should not be physically replaced due to cybersecurity concerns.

Still, even though there's not a ton of risk of having your pacemaker hacked in public, the FDA recommends that patients with the device make an appointment with their doctors to get the firmware update. Patients will need to visit their doctors to receive the update, which is delivered by holding a wand over the site of the implant.

Discuss the risks and benefits of the cybersecurity vulnerabilities and associated firmware update with your patients at the next regularly scheduled visit. About 280,000 devices are eligible for the update outside the U.S., Candace Steele Flippin, a spokesperson for Abbott said.

Patients with unpatched devices are vulnerable to hacking.

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The FDA said there are no known cases of patient harm stemming from the bugs found in devices. Once the hacker has control, they can rapidly deplete the battery or alter the pacing, putting the health of patients who rely on their pacemakers at risk.

The St. Jude Medical pacemaker flaws that an investor relied on to short the company's stock has a new patch to address the issue.

The FDA has approved a firmware update for radio frequency-enabled cardiac pacemakers sold by St. Jude Medical (since acquired by Abbott) to rectify vulnerability to "cybersecurity intrusions and exploits", the agency said Tuesday. The Merlin Programmer and Merlin@home Transmitter will provide the authorization. This home monitor wirelessly reads and shares data stored on implanted cardiac devices.

The result of which would drain battery power or the administration of inappropriate pacing. "Abbott is resolving all old St. Jude Medical issues".

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There haven't been any reports of the vulnerability being exploited in the wild, according to the FDA.

"Your firm did not confirm all required corrective and preventive actions were completed, including a full root cause investigation and the identification of actions to correct and prevent recurrence of potential cybersecurity vulnerabilities, as required by your CAPA procedures", the FDA wrote in its warning letter.

In May, cybersecurity researchers published a report highlighting thousands of vulnerabilities in four pacemaker manufacturers.

"For pacing dependent patients, consider performing the cybersecurity firmware update in a facility where temporary pacing and pacemaker generator can be readily provided", according to the alert.

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