As individuals continue to deal with the consequences of a St. Jude defibrillator battery recall issued last year, federal regulators are notifying doctors that there is a new tool available to help predict battery failure for the implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Last week, the FDA announced an update to the St. Jude ICD and CRT-D recall originally issued on October 20, 2016. New information has been provided about a “St. Jude’s Battery Performance Alert (BPA)”, which is a management tool designed to provide earlier detection of imminent battery failure for the implanted heart devices.
The battery problems have plagued certain St. Jude Fortify, Unify and Assura defibrillators, which could experience rapid battery failure. At least two deaths and dozens of adverse events have been linked to the issue.
Additionally, the agency issued a warning letter to St. Jude in April, 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.
St. Jude issued a Dear Doctor letter (PDF) in late August, announcing the BPA software. The new software was sent out through the company’s Merlin.net wireless network to upgrade patients’ remote monitoring systems.
According to St. Jude, the software uses an algorithm that can detect abnormal battery performance before the batteries fail. If the alert is triggered, the company recommends the device immediately be removed and replaced.
“Battery information is uploaded automatically each night to Merlin.net where the most recent 32 days of data are analyzed each day to determine if an anomalous battery voltage trend is observed,” St. Jude wrote to its customers. “Once the BPA is triggered, notification is provided to physicians through the Merlin.net monitoring system and the Merlin programmer during routine follow-up evaluations. For patients not followed remotely with Merlin.net, the status of their battery and whether the BPA has triggered an alert can only be determined with in-person interrogation using the Merlin programmer.”
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.
St. Jude has said that it was unable to confirm the problem until the recall was announced last year. Consumers and doctors with questions regarding the recall, monitoring and the new software can contact a local sales representative or call Abbott Technical Services at 1-800-722-3774.