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October 31, 2016. Category: Unsafe Medical Devices

St. Jude Defibrillators May Malfunction

Heart defibrillators are incredibly important for patients with heart rhythm abnormalities. Whether a patient is experiencing slow heart rhythms or dangerously fast heart beats, implantable heart defibrillator devices can literally be the difference between life and death.  Sadly, new reports indicate there could be serious safety concerns with certain models of St. Jude heart defibrillators made before 2015.

Battery Malfunctions Could Lead to Death

This month, St. Jude Medical Inc. warned patients and the medical community that batteries currently in hundreds of thousands of implanted heart defibrillators could quickly and unexpectedly lose power and stop functioning, potentially resulting in patient death.

The company issued the warning after two patients with St. Jude defibrillators died as a result of their batteries running down prematurely. Typically, when the batteries begin to run down, patients will feel the implant vibrate for 16 seconds (think of it similar to the way those devices at restaurants alert you when your table is ready).  From the time of the first vibration, patients then have three months to get the batteries replaced. This allows for plenty of time to schedule an appointment around other daily activities, while still knowing that the battery is safe and properly functioning. However, the devices involved in the recall ran down at an alarming rate — between 24 hours and a few weeks after the first alert.

Around 350,000 patients around the world currently have the potentially defunct devices, which were made before 2015. Thus, St. Jude recommends that patients pay close attention to their devices and contact their doctors as soon as they are notified that their batteries are running low.

Although death is a possibility, device malfunction could also cause fainting and dizziness. So it’s best to be aware of the battery depletion so that any and all side effects can be avoided. Chief Medical Officer Mark Carlson explained, “We are recommending that patients utilize remote monitoring, to enable their physicians to monitor their devices’ performance over time,” in the hopes that physicians and patients can mitigate the risk of dangerous side effects.

Alley, Clark & Greiwe Is Here For You

If you or a loved one suffered serious injury as a result of a defective heart defibrillator, please contact us today for a free consultation regarding your legal rights.  

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