The U.S. Food and Drug Administration (FDA) has revealed that 10 people have fainted and two people have died after the batteries in their heart defibrillators ran out.
The devices, which are made by St. Jude Medical, failed much earlier than expected due to a rare defect. St. Jude advised that the device would give off an alert that is electronic and vibrates, which warns patients that they need to replace their batteries straight away. However, batteries will normally need replacing up to three months after this signal. Now the company has said that just 24 hours after this alert, a small number of their defibrillators can fail.
A buildup of deposits
These devices are powered by lithium batteries, and it is a buildup of deposits around these that has caused the design flaw. St. Jude advised that they fixed the problem in May 2015, removing all of the devices that had been affected from hospital inventories and distribution. In a separate statement released by the FDA, they claimed that there could be up to 350,000 patients around the world whose devices could be affected by the same issue.
Having the device preemptively removed isn’t something that regulators are recommending as surgical risks are much higher than the possible harming defect in most cases. As St. Jude revealed, premature battery depletion hasn’t been experienced in the majority of the devices that have been sold worldwide.
Other manufacturers have had recalls
However, companies looking to have similar devices approved may be wondering, where can I find a contract research organization, as they try to avoid having similar life-threatening problems with their own devices. A contract research organization might be able to help with their approval process.
Many of the major manufacturers of similar devices have had recalls and have reported malfunctions, including St. Jude’s competitors Boston Scientific and Medtronic Inc.
St. Jude also had to stop selling a certain specification of their defibrillators in 2010 as premature cracks and failures could be experienced because of the wires that were used in them. To settle the lawsuits that were filed against them by customers who had received these devices with faulty wires, they had to pay out $14.5 million. St. Jude Medical Inc. shares fell by 3.5 per cent.