St. Jude Medical, Inc. (NYSE:STJ), which is currently in talks with Abbott Laboratories (NYSE:ABT) for a possible $25-billion acquisition, has recently revealed that a battery malfunction in roughly 350,000 implanted heart defibrillators can cause the devices to lose power. The affected devices have been manufactured by St. Jude Medical until 2015.
According to the US Food and Drug Administration (FDA), two patients already died after their heart defibrillators had shut down due to the said battery malfunction. Ten patients have also reported fainting occurrences due to the same problem while nearly 40 patients have experienced dizziness.
St. Jude Medical has reassured that it is closely working with regulators and healthcare professionals to prevent fatalities resulting from such rare problem and to help implanted patients.
The implanted heart defibrillators facilitate pacing for slow heart rhythms. When the battery runs low on power, the patients will be notified. This gives them a three-month window to replace the devices.
However, with the battery malfunction, the implanted heart defibrillators can lose power in just 24 hours.
“If the battery runs out, the (devices) will be unable to deliver lifesaving pacing or shocks, which could lead to patient death,” explained the US FDA.
Will It Affect Abbott Laboratories Deal?
Scott Stoffel, a St. Jude Medical spokesperson, has guaranteed that the company’s financial status will not be substantially affected by the recall of hundreds of thousands of malfunctioning devices. He has reiterated that the deal is still expected to close by year-end.
By far, 841 out of more than 350,000 malfunctioning implanted heart defibrillators have already been returned to the company.
The company has advised patients to closely monitor the implanted heart defibrillators. Affected patients are highly recommended to return the devices to St. Jude Medical as soon as they receive a low-battery alert.
The company has already come up with new battery designs last year.
St. Jude Medical has declined 3.53% to $78.41 on Tuesday while Abbott Laboratories has lost 5.38% to $41.16.