Gallant CRT-D Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · CRT-Defibrillator (CRT-D) · First cleared May 2024 · 7 device variants grouped
Total Reports
9,362
Reports (30d)
157
Active Signals
2
Open Recalls
2
What the reports describe · Claripulse analysis
Most commonly reported problems
Remote Oversensing via Merlin.net
net, remotely merlin, net review, merlin net, presented remotely
59
reports
Remote Oversensing Monitoring in Stable Condition
observed device, remote follow, support contacted, paced wave, oversensing pptwos
43
reports
Infection at Device Pocket Site
right, lead, infection, pocket, patient presented
31
reports
Post-Paced T-Wave Oversensing Observation
exhibited post, paced wave, oversensing pptwos, patient implantable, icd exhibited
29
reports
T-Wave Oversensing Programming Discussion
implantable cardioverter, programming changes, cardioverter defibrillator, defibrillator icd, oversensing
21
reports
Inappropriate Shock Delivery
icd, implantable cardioverter, cardioverter, cardioverter defibrillator, inappropriate
18
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
The Gallant™ System Heart Rhythm Management Device: Making a Connection
Raffaele Corbisiero, et al. · Future Cardiology · 2022
Cardiac implantable electronic device malfunction after pulsed field ablation-insights from the MAUDE database.
Yamamoto T, et al. · Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026
Citations indexed from PubMed.
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