Allure Quadra Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · CRT-Defibrillator (CRT-D) · First cleared May 2004
Total Reports
315
Reports (30d)
1
Active Signals
0
Open Recalls
2
What the reports describe · Claripulse analysis
Most commonly reported problems
Premature Battery Depletion Observed
implantable cardioverter, icd, battery, replaced, cardioverter defibrillator
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
Profile of St. Jude Medical's Allure Quadra quadripolar pacemaker system for cardiac resynchronization therapy.
Corbisiero R, et al. · Expert review of medical devices · 2014
Case of Frozen Leads: An Old but Persistent Challenge
Takamasa Ishikawa, et al. · Pacing and Clinical Electrophysiology · 2025
Cardiac Resynchronization Therapy Delivered Via a Multipolar Left Ventricular Lead is Associated with Reduced Mortality and Elimination of Phrenic Nerve Stimulation: Long-Term Follow-Up from a Multicenter Registry.
Behar JM, et al. · Journal of cardiovascular electrophysiology · 2015
Citations indexed from PubMed.
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