Recalls

Battery Performance Alert available for faulty heart devices

ucm581193 Battery Performance Alert available for faulty heart devicesSt. Jude Medical announced an update to the Food and Drug Administration’s (FDA) October 2016 recall notice to inform about the availability of the Battery Performance Alert (BPA), a new battery performance management tool that detects and notifies physicians of abnormal battery performance that may lead to premature battery depletion in the company’s Implantable Cardioverter Defibrillators.

St. Jude Medical’s Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms.

Both ICDs and CRT-Ds are implanted under the skin in the upper chest area with connecting insulated wires called “leads” that go into the heart. Patients need an ICD or CRT-D if their heartbeat is too slow (bradycardia), too fast (tachycardia), or needs coordination to treat heart failure.

In October 2016, St. Jude Medical notified physicians and patients that a subset of its ICDs and CRT-Ds manufactured between January 2010 and May 2015 could potentially experience premature battery depletion.

The new Battery Performance Alert uses an algorithm to detect abnormal battery behavior in affected devices. The Battery Performance Alert is available for the following devices subject to the October 2016 Medical Device Advisory: Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, and Unify Quadra.

To determine whether a device is subject to the 2016 advisory, patients should refer to St. Jude Medical’s online update. Patients whose devices are subject to this recall should contact their doctors for additional information including any specific questions related to this advisory. Any adverse events with these devices should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA Recall Notice