EMBLEM S-ICD Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Implantable Cardioverter Defibrillator (ICD) · First cleared Sep 2012 · 9 device variants grouped
Total Reports
37,761
Reports (30d)
402
Active Signals
6
Open Recalls
12
What the reports describe · Claripulse analysis
Most commonly reported problems
Inappropriate Shock from T-Wave Oversensing
amplitude, icd delivered, subcutaneous, subcutaneous implantable, shock
202
reports
Inappropriate Shock from Noisy Signals
noise, subcutaneous, secondary, inappropriate, vector
153
reports
High Shock Impedance Measurements
measurements, shock, impedance, technical services, shock impedance
69
reports
Battery Depletion Analysis Requested
battery, subcutaneous implantable, request data, data, device analyzed
61
reports
Inappropriate Shock from Oversensing
icd delivered, reported subcutaneous, shock, subcutaneous implantable, inappropriate
60
reports
Premature Battery Depletion Confirmed
depletion, battery, reported subcutaneous, subcutaneous implantable, request data
51
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
Aug 20, 2025 · Open, Classified
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Jul 24, 2025 · Open, Classified
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Nov 30, 2023 · Open, Classified
The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.
Jul 11, 2023 · Open, Classified
There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
Jul 11, 2023 · Open, Classified
There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
Feb 2, 2023 · Open, Classified
Under specific circumstances, the U.S. product registration system did not send up enablement requests to U.S. LATITUDE Customer Support during an 8-month interval in 2022. For these patients, the HeartLogic Index and any associated Yellow Alerts are currently not visible in LATITUDE as may have been intended by the healthcare provider..
Keep exploring
Related devices in CRM
CAPSUREFIX Novus
MEDTRONIC, INC. · 44,929 reports
Sprint Quattro Secure S MRI SureScan
MEDTRONIC, INC. · 37,430 reports
CapSureFix Novus MRI SureScan
MEDTRONIC, INC. · 28,090 reports
Durata
ABBOTT (ST. JUDE MEDICAL) · 19,969 reports
Quadra Assura MP
ABBOTT (ST. JUDE MEDICAL) · 10,531 reports
LINQ II
MEDTRONIC, INC. · 9,526 reports
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 6 active signals detected right now.
Get Early AccessUnderstanding this data