St. Jude Medical issues warning on defibrillator after malfunction is linked to patient deaths
Almost 400,000 cardioverter defibrillators and cardiac resynchronization defibrillators could stop working with 24 hours notice, system says.
St. Jude Medical has issued a warning regarding its implanted defibrillators after reports that a malfunction was linked to two patient deaths.
The company said they could stop working after rapidly losing their power, and the battery depletion is due to lithium deposits in a subset of the devices manufactured prior to May 23, 2015. St. Jude has stressed that the issues occurred in a small percentage of the devices -- 0.21 percent, to be exact -- but according to published reports, the problem has so far been linked to two patient deaths.
Almost 400,000 cardioverter defibrillators and cardiac resynchronization defibrillators could stop working with as little as 24 hours notice. The devices provide pacing for slow heart rhythms, and electrical shock or pacing to correct fast heart rhythms. Low-voltage items such as pacemakers are not affected.
In conjunction with regulatory agencies and its own medical advisory board, St. Jude has offered a number of recommendations for physicians and patients.
First, the company has asked physicians to contact their patients to notify them of the issue; the device would only need replacing if physicians determine it's needed, the company said.
[Also: St. Jude Medical restructures, eliminates 300 jobs]
It also recommended to patients that they enroll in Merlin.net remote monitoring services where they are available. The service notifies a physician when the device's battery is nearing depletion.
St. Jude has said it would provide the service at no cost.
St. Jude also warned patients they should immediately contact their physician if their device vibrates, which signals imminent battery depletion. Patients can learn if their device is in the advisory by going to www.sjm.com/batteryadvisory.
If the decision is made to replace an affected device based on a patient's circumstances, St. Jude Medical will provide a replacement device at no cost.
St. Jude is in the process of being acquired by Abbott Laboratories in a cash-and-stock deal initially valued at $25 billion.
Twitter: @JELagasse
