Quartet Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · CRT-Defibrillator (CRT-D) · First cleared Nov 2018 · 9 device variants grouped
Total Reports
8,684
Reports (30d)
84
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
172
reports
Pocket Infection and Erosion
right, lead, infection, pocket, patient presented
21
reports
Infection with Lead Explantation
explanted, icd, lead, right, infection
9
reports
Remote Monitoring Oversensing Episodes
net, remotely merlin, net review, merlin net, presented remotely
7
reports
Explanted Due to Bacteremia Infection
infection, patient stable, procedure patient, patient complications, explanted
2
reports
ICD in Backup Mode Post-MRI
mode, implantable cardioverter, icd, cardioverter defibrillator, mri
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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