Quadra Assura Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · CRT-Defibrillator (CRT-D) · First cleared Apr 2018
Total Reports
3,002
Reports (30d)
0
Active Signals
0
Open Recalls
2
What the reports describe · Claripulse analysis
Most commonly reported problems
Device in Backup Mode Post-MRI
support contacted, resolve event, technical support, mri, mode
1
reports
Device Oversensing During Follow-Up
observed device, support contacted, technical support, pptwos, device technical
1
reports
Dislodged Left Ventricular Lead
left, lead, replaced, left ventricular, ventricular lead
1
reports
Explanted Due to ERI Status
battery, device remains, explanted replaced, remains, explanted
1
reports
ICD in Backup Mode Post-MRI
mode, implantable cardioverter, icd, cardioverter defibrillator, mri
1
reports
Inappropriate Shock Delivered by ICD
implantable cardioverter, icd, shock, cardioverter defibrillator, defibrillator icd
1
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
Canadian Registry of Electronic Device Outcomes (CREDO): The Abbott ICD Premature Battery Depletion Advisory, a Multicentre Cohort Study.
Davis J, et al. · CJC open · 2020
Dealing with RV‐oversensing; separate sensitivity settings for brady and tachy sensing
Pranav Bhagirath, et al. · Journal of Cardiovascular Electrophysiology · 2020
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
Acute hemodynamic impact of atrioventricular delay and left ventricular pacing vector programming in MultiPoint Pacing
Wei Hua, et al. · Pacing and Clinical Electrophysiology · 2022
Extending multipoint pacing CRT battery longevity by swapping left ventricular pulse configurations
Juan J. García Guerrero, et al. · Journal of Interventional Cardiac Electrophysiology · 2020
Citations indexed from PubMed.
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