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2 Deaths Linked to St. Jude Heart Defibrillators

”defective medical device

St. Jude Medical has issued an advisory to patients using the company’s heart defibrillators. The advisory is in response to two deaths  that were linked to battery failures in the devices..

Nearly 400,000 Potentially Defective St. Jude Defibrillators on the Market

According to CNN, 398,740 of the St. Jude Medical implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) are prone to battery failure and premature battery depletion. Losing battery power can prevent the devices from pacing heartbeats or delivering life saving shocks, possibly resulting in fatal outcomes for patients.

The CRT-Ds and ICDs are implanted under the skin in the upper chest area. During the implant procedure, wires from the devices, referred to as leads, are attached to the heart to help regulate the rhythm of the muscle in patients with fast and slow heartbeats through pacing and shocks.

So far, two deaths have been linked to the devices. In both instances, the defibrillators failed to deliver needed shock therapy due to premature battery depletion.  An additional 10 patients reported fainting due to devices failing to provide pacing therapy, and 37 patients reported dizziness due to lack of pacing therapy.

What is Causing the Battery Failures?

Investigators state that buildup of lithium material in the batteries can cause the batteries to short-circuit, resulting in premature depletion.

Normally, the batteries last seven to 10 years before depletion. Further, when the battery is nearing the end of its life, indicators built into the devices will notify patients through vibrations in the chest. A patient will then have roughly three months before the device dies.

With the current battery failures, patients are losing battery power within a week of receiving notification from the device. In some instances, devices have failed within a day of alerting patients of battery depletion.

How Should Patients Respond to a Defective Defibrillator?

Patients are urged to check the device date on their defibrillator, affected devices were manufactured before May 2015.  Patients can also enter their device’s model number and serial number at www.sjm.com to determine if they are subject to the advisory.

The U.S. Food and Drug Administration (FDA) urges affected patients to contact their physician immediately after feeling a vibratory alert. In the event of a low-battery notification, St. Jude Medical recommends an immediate device change.

For additional protection, patients can register their devices for home monitoring. This will alert physicians when the defibrillator battery is nearing the end of its life.

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