Abbott Laboratories has issued a firmware update, which is designed to address cybersecurity risks and battery problems with St. Jude ICD and CRT-D devices, which the FDA considers a recall due to the importance of the corrective action.
According to a safety communication issued by the FDA on April 17, patients and caregivers for individuals with certain St. Jude Medical implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices should consult with their physician to determine when they should receive the firmware update.
The recall impacts certain defibrillators manufactured by Abbott (formerly St. Judge Medical), including devices from the following ICD and CRT-D families of products: Current, Promote, Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, Unify Quadra, Promote Quadra and Ellipse.
The action comes following St. Jude ICD/CRT-D battery problems that have plagued certain devices in recent years, resulting in reports of rapid battery failure, which may has been blamed for several deaths and adverse event reports in recent years.
In April 2017, the FDA issued a warning letter to St. Jude, indicating that investigators have discovered that at least 10 recalled defibrillators were shipped out after the problem was identified, and seven had been implanted in unsuspecting patients.
The agency approved the latest firmware update on April 11, which is designed to reduce the risk of premature battery depletion and address potential exploitation issues.
“The firmware update requires an in-person patient visit with a health care provider — it cannot be done from home via the Merlin.net,” the FDA indicates. “The update process will take approximately three minutes to complete.”
The agency warns that there is a low risk of malfunction associated with the updates that could result in discomfort due to backup pacing settings, the need to reload previous firmware versions due to an incomplete update, the risk of an inability to treat ventricular tachycardia/fibrillation while in back-up mode, the device remaining in backup mode due to an unsuccessful update, and potential loss of currently programmed device settings or diagnostic data.
A number of lawsuits over St. Jude defibrillator battery problems have been filed, including class action claims on behalf of insurers who covered the cost of buying and replacing the devices, as well as individual injury cases. Plaintiffs allege that St. Jude knew about the potential risk of defibrillator battery problems as early as 2011, but continued to distribute implants they knew could fail prematurely, without disclosing the risks.
The FDA is recommending doctors conduct the firmware update for all eligible patients, print or digitally store the programmed device settlings and diagnostic data in case it is lost, and confirm that the devices maintain their functionality and are not in backup mode.
Doctors with questions can contact their Abbott representative, or Abbott’s customer technical support hotline at 1-800-436-5056.