Unify Assura Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · CRT-Defibrillator (CRT-D) · First cleared Apr 2018 · 8 device variants grouped
Total Reports
4,739
Reports (30d)
16
Active Signals
0
Open Recalls
2
What the reports describe · Claripulse analysis
Most commonly reported problems
Device Unable to be Interrogated
implantable cardioverter, icd, patient implantable, cardioverter defibrillator, defibrillator icd
5
reports
Remote Oversensing via Merlin.net
net, remotely merlin, net review, merlin net, presented remotely
5
reports
Unknown Cause of Patient Death
atrial, additional information, infection, lead, atrial fibrillation
4
reports
Post-Paced T-Wave Oversensing Monitoring
observed device, support contacted, resolve event, recommended reprogramming, technical support
3
reports
Under-Sensing on Implantable Cardioverter
patient consequences, consequences reported, implantable cardioverter, sensing, cardioverter defibrillator
3
reports
Infection at Device Pocket Site
right, lead, infection, pocket, patient presented
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
FDA recalls for this device
Aug 16, 2023 · Open, Classified
Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that were manufactured prior to April 2022 as a result of crystal component issue within the Bluetooth Low Energy (BLE) circuit. This results in the device entering an inductive telemetry only mode with loss of Bluetooth communication. In some instances, thought BLE communication is unavailable, the circuit may remain in a state which draws excessive power affecting battery longevity.
Mar 10, 2022 · Open, Classified
Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.
Evidence
Related research
Long-term reverse remodeling and clinical improvement by MultiPoint Pacing in a randomized, international, Middle Eastern heart failure study
Abdulmohsen Almusaad, et al. · Journal of Interventional Cardiac Electrophysiology · 2021
Canadian Registry of Electronic Device Outcomes (CREDO): The Abbott ICD Premature Battery Depletion Advisory, a Multicentre Cohort Study
Jason S. Davis, et al. · CJC Open · 2020
Citations indexed from PubMed.
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