Software issue which can lead to loss of device sensing.
ANZCDACC Management Recommendations for Boston Scientific EMBLEM S-ICD Alert
October 2023
Device: EMBLEM S-ICD Model A209 and EMBLEM MRI S-ICD A219
TGA Reference: RC-2023-RN-00850-1
Australian Register of Therapeutic Goods (ARTG): 399595 and 399599
Medsafe Notification Reference: 31906
Advisory grade TGA: Class II
Description:
During an EMBLEM S-ICD system, low energy pulses are automatically sent every 3 days.
Sensing is momentarily disabled when this test is performed to prevent non-cardiac artifacts
from being over-sensed by the device.
If telemetry from a LATITUDE communicator is initiated within a 700 millisecond interval
during an automatic system impedance check, the impedance measurement will cease and be
postponed for a 24 hour interval. During this postponement interval, sensing will be temporarily
disabled until the next rescheduled impedance measurement is completed.
Number of devices affected in Australia and New Zealand: 1868
Presentation:
This advisory only affects EMBLEM S-ICD devices that are enrolled in the LATITUDE Remote
Patient Management System. As sensing becomes disabled during the 24-hour postponement
interval, there is a risk that shock therapy will not be delivered during this period.
Rate of occurrence:
Three reports of this rare behaviour have been reported out of approximately 136,000 EMBLEM
S-ICD devices, none of which have occurred in Australia. The one-year likelihood for the
theoretical risk of death due to failure to treat a life-threatening arrhythmia because of this
behaviour is 1 in 45 million.
Recommendation:
Boston Scientific Has launched a software update for Model 3300 LATITUDE and Model 3200
EMBLEM programmers to address this rare, transient sensing behaviour in the EMBLEM S-
ICD.
All patients with the EMBLEM S-ICD models A209 and A219, who are enrolled in the
LATITUDE Remote Patient Management System, should be checked in-person at next
scheduled follow-up using an updated Model 3300 LATITUDE or Model 3200 EMBLEM
programmer.
Ensure that the software version (S-ICD Support App Model 3877) is updated to version 1.04.
This information can be found under the ‘About’ menu on the start-up screen of the
programmers.
The ANZCDACC encourage you to report any adverse event or near (potential) adverse
event associated with the use of a medical device including any abnormal CIED or lead
function. We encourage reporting to ANZCDACC directly via the Committee chair Dr
Paul Gould [email protected] and to the following regulators.
In Australia, report to the TGA:
Online: https://www.tga.gov.au/reporting-problems
In New Zealand, report to Medsafe:
Post: Compliance Management Branch, Medsafe, PO Box 5013, Wellington 6145
Email: [email protected]