St. Jude Medical heart defibrillators have been linked to two deaths after their batteries failed at crucial moments.
The company has now issued a warning to the 400,000 people who currently use the device in order to regulate their heart beats.
They are asking that doctors who have implanted the device into their patients not to act too quickly and remove it, but instead to check the device and monitor how it is working much more closely.
According to St. Jude Medical, the device is supposed to give out an Elective Replacement Indicator (ERI) signal three months before the battery goes.
Defibrillators are implanted into the patient’s upper chest. Wires are attached to the heart muscle to help patients who have a slow heartbeat speed up the rhythm, or slow down heartbeats that are too fast with an electric shock. These devices are called Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
The FDA said of the recent tragedies:
“If the battery runs out, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death. The patients most at risk are those with a high likelihood of requiring life-saving shocks and those who are pacemaker dependent.”
The premature battery shortage is thought to be due to a build up of lithium within the device. The flaw is in pacemakers that were created before 2015.
St. Jude states that most of the devices are not subject to premature battery depletion and that most people who have the device implanted should be okay in the following statement:
“The likelihood that this will impact your health is low, as the vast majority of devices have not experienced premature battery depletion. We have asked physicians to contact their patients with information about this advisory. Device replacement is not recommended unless the physician determines otherwise.”
However, several other people have reported problems with the device that were fortunately not life-threatening.
Nine people in the United States, 10 in total, reported fainting due to an issue with their device.
A further 37 people have said that they felt dizzy after their defibrillator did not work properly.
Anyone concerned about the battery depletion issue can go to their website here.