FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Boston Scientific Warns of Weaker Battery Life on Older Defibrillator Models

Aug. 28, 2019
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A small number of Boston Scientific’s older Emblem subcutaneous implantable cardioverter defibrillators (S-ICDs) and MRI S-ICDs have a higher risk of fast battery depletion, the devicemaker announced.

Approximately 400 of the devices have a 19 percent chance after three years of an electrical component causing the battery to drain faster, leading to early device replacement. The behavior can be identified by an unexpected decrease in battery capacity or by an early replacement or dead battery indicator.

The affected devices were manufactured in July 2017 and are no longer available for implant, the company said.

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