Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its subset of Model A209 EMBLEM S-ICDs and Model A219 EMBLEM MRI S-ICDs.
The manufacturer informs about the performance of approximately 400 active worldwide EMBLEM S-ICDs that may result in a need for device replacement (Elective Replacement Indicator ERI/ End of Life EOL) earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.
While EMBLEM S-ICDs demonstrate an overall cumulative device survival of 99.6% at 3 years, the subset of active devices exhibit an elevated likelihood (19% at 3 years) of an electrical component causing accelerated battery depletion. The affected device are manufactured in July 2017 and are no longer available for implant.
According to the manufacturer, the most common outcome of this behavior is early device replacement. There have been no other serious injuries reported for this behavior. This behavior can be detected by observing an unexpected decrease in battery capacity or an early ERI or EOL battery status. Devices exhibiting this behavior have been capable of providing therapy for a minimum of 21 days after ERI.
Affected users are recommended to take actions on the issues mentioned in the manufacturer's Medical Device Advisory.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 27 August 2019