Quartet Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · CRT-Defibrillator (CRT-D) · First cleared Nov 2018 · 10 device variants grouped
Total Reports
8,753
Reports (30d)
67
Active Signals
1
Open Recalls
2
What the reports describe · Claripulse analysis
Most commonly reported problems
Dislodged Left Ventricular Lead
left, lead, replaced, left ventricular, ventricular lead
173
reports
Infection at Device Pocket Site
right, lead, infection, pocket, patient presented
31
reports
Remote Oversensing via Merlin.net
net, remotely merlin, net review, merlin net, presented remotely
6
reports
Unknown Cause of Patient Death
atrial, additional information, infection, lead, atrial fibrillation
3
reports
System Explanted Due to Infection
additional information, infection, patient stable, following, explanted
3
reports
RV Lead Oversensing and Pacing Inhibition
defibrillator crt, crt, lead, use, high
1
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.
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