FDA Warns Battery-Failure Risk for Some St Jude ICDs, CRT-Ds

Larry Hand

October 11, 2016

SILVER SPRING, MD — The US Food and Drug Administration (FDA) issued a MedWatch safety alert today regarding premature battery depletion in some implantable cardioverter defibrillators (ICDs) and cardiac-resynchronization-therapy defibrillators (CRT-Ds) manufactured by St Jude Medical[1].

Batteries in some devices manufactured prior to May 2015 have fully drained within a day after the devices issued an elective replacement indicator (ERI) alert, instead of the normal 3-month lead time, according to the FDA.

The specific devices, included in the Fortify, Unify, and Quadra product lines, are listed on another FDA communication[2]. St Jude Medical also issued a Dear Patient letter posted on its website.

In its safety alert, the FDA listed several recommendations for healthcare providers, including:

  • Do not implant affected devices.

  • Communicate the alert to patients with affected devices.

  • Follow up on patients with affected devices.

  • Immediately replace devices upon receipt of an ERI alert.

  • Treat as a medical emergency pacemaker-dependent patients with a device-issued ERI alert.

  • Ensure that all patients have their ERI battery alert turned on.

  • Enroll patients in St Jude Medical's remote monitoring system, Merlin@home.

If a decision to replace a device is made, based on individual patient assessment, St Jude will provide a replacement device at no cost, the company says.

In lithium-based batteries, lithium clusters can create abnormal electrical connections, which lead to rapid battery failure, according to the FDA.

Of the almost 400,000 affected devices sold worldwide, almost 850 have been returned for analysis due to premature battery depletion, and two deaths (one in the US) have been associated with devices that could not provide needed shock therapy due to the battery depletion.

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