Hundreds of thousands of lives depend on St. Jude’s pacemakers. Yet concerns over battery problems and cybersecurity issues have been topics of news stories, lawsuits, and patient outcry.
Our St. Jude pacemaker lawyers are currently representing clients seriously hurt by these defibrillators. Many of our clients were affected by the St. Jude recalls in the fall of 2016, and we know many other patients may be worried about the cybersecurity issues. We explain those problems below.
WHO NEEDS A PACEMAKER?
Pacemakers monitor the heartbeat and send electrical pulses to regulate it. Doctors typically recommend the device to patients whose hearts are damaged from aging or heart attacks.
Despite past battery failure recalls, 465,000 people in the U.S. are still implanted with St. Jude pacemakers.
BATTERY FAILURE RECALL
In October 2016, the FDA issued a recall for short circuiting batteries causing premature failure. The normal life for a St. Jude pacemaker is seven years, but those with defective batteries fail in three to four years.
A new federal lawsuit claims that St. Jude Medical, now owned by Abbott, failed to warn the public of some 250,000 pacemakers with defective batteries implanted between October 2011 and October 2016.
At the time, St. Jude advised doctors against recommending replacement because risks, like infection, outweighed the risk of battery failure. Still today, patients are experiencing battery failures.
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New cybersecurity weaknesses are another big threat to the health and safety of these patients.
WHICH MODELS ARE AFFECTED?
While the company has not received any reports of devices being hacked into, there’s still an increased risk that the device’s weaknesses can be exploited, said one FDA representative.
The models addressed in this security scare include:
- Accent MRI
- Accent ST
UPDATE FROM ABBOTT
As with all tech products, pacemakers need to be updated once in a while.
Abbott has created a firmware update that will provide pacemakers with extra security to prevent hackers from reprogramming the devices to run down the batteries or change a patient’s heartbeat.
Every pacemaker produced after August 28, 2017 will have this new update. Abbott states that the new updates are not necessary and that patients who already have a pacemaker should not worry about having it updated or replaced.
Patients who want the new security update should speak to their doctors to find out if they need it. The update takes about three minutes to install, and would be an obstacle for hackers because they would need authorization to access a patient’s pacemaker.
The software update is an easier, and less expensive, process than implanting a newer pacemaker with the already-included update.
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PINTAS AND MULLINS CAN HELP YOU
If you’ve been seriously injured by a St. Jude Pacemaker battery failure, contact one of our defective medical device lawyers today. Compensation may be available to patients who have required surgery or suffered other complications from the device’s defects.