Quadra Assura MP Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · CRT-Defibrillator (CRT-D) · First cleared Apr 2018 · 9 device variants grouped
Total Reports
10,671
Reports (30d)
22
Active Signals
1
Open Recalls
2
What the reports describe · Claripulse analysis
Most commonly reported problems
Remote Oversensing Monitoring in Stable Condition
observed device, remote follow, support contacted, paced wave, oversensing pptwos
12
reports
Remote Oversensing via Merlin.net
net, remotely merlin, net review, merlin net, presented remotely
10
reports
Dislodged Left Ventricular Lead
left, lead, replaced, left ventricular, ventricular lead
6
reports
Post-Paced T-Wave Oversensing Observation
exhibited post, paced wave, oversensing pptwos, patient implantable, icd exhibited
6
reports
Post-Paced T-Wave Oversensing Programming Change
sensing, programming changes, patient presented, patient consequences, consequences reported
5
reports
Infection at Device Pocket Site
right, lead, infection, pocket, patient presented
5
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 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
Dealing with RV‐oversensing; separate sensitivity settings for brady and tachy sensing
Pranav Bhagirath, et al. · Journal of Cardiovascular Electrophysiology · 2020
Acute hemodynamic impact of atrioventricular delay and left ventricular pacing vector programming in MultiPoint Pacing
Wei Hua, et al. · Pacing and Clinical Electrophysiology · 2022
Multipoint pacing is associated with improved prognosis and cardiac resynchronization therapy response: MORE-CRT MPP randomized study secondary analyses
Leonardo Calò, et al. · EP Europace · 2024
Extending multipoint pacing CRT battery longevity by swapping left ventricular pulse configurations
Juan Jose Garcia Guerrero, et al. · Journal of Interventional Cardiac Electrophysiology · 2020
Visualization of the SyncAV® Algorithm for CRT Optimization by Non-invasive Imaging of Cardiac Electrophysiology: NICE-CRT Trial
Philipp Spitaler, et al. · Journal of Clinical Medicine · 2023
Citations indexed from PubMed.
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