Gallant CRT-D Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · CRT-Defibrillator (CRT-D) · First cleared May 2024 · 5 device variants grouped
Total Reports
9,178
Reports (30d)
172
Active Signals
2
Open Recalls
2
What the reports describe · Claripulse analysis
Most commonly reported problems
Remote Monitoring Oversensing Episodes
merlin net, net review, presented remotely, net, remotely merlin
66
reports
Post-Paced T-Wave Oversensing Observed
oversensing, contacted recommended, implantable cardioverter, observed device, support contacted
57
reports
Remote Follow-Up Oversensing Observed
observed device, remote follow, technical support, device technical, stable continue
21
reports
Inappropriate Shock Delivered by ICD
implantable cardioverter, icd, shock, cardioverter defibrillator, defibrillator icd
21
reports
Post-Paced T-Wave Oversensing Reported
patient consequences, consequences reported, sensing, programming changes, patient implantable
18
reports
Dislodged Left Ventricular Lead
left, lead, replaced, left ventricular, ventricular lead
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
A novel etiology for automatic mode switching and ventricular noise reversion alerts: pulsed field ablation.
Lampert J, et al. · HeartRhythm case reports · 2024
Citations indexed from PubMed.
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