ABBOTT (ST. JUDE MEDICAL) · CRT-Defibrillator (CRT-D) · First cleared Apr 2018
Total Reports
2,986
Reports (30d)
3
Active Signals
1
Open Recalls
2
What the reports describe · Claripulse analysis
Remote Follow-Up Oversensing Observed
observed device, remote follow, support contacted, resolve event, technical support
3
reports
Remote Follow-Up Oversensing Episodes
follow episodes, remote follow, episodes post, oversensing pptwos, device technical
2
reports
ICD in Backup Mode with No Therapy
mode, icd, implantable cardioverter, cardioverter, cardioverter defibrillator
1
reports
In-Clinic Oversensing Episodes Observed
support contacted, reprogramming, resolve event, episodes post, technical support
1
reports
Inappropriate Therapy for Tachycardia
crt, atrial, therapy, tachycardia, ventricular tachycardia
1
reports
Infection with Device Pocket Erosion
explanted, icd, infection, pocket, ventricular lead
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
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
Acute Effects of Fusion Pacing Versus Standard CRT on Myocardial Function in Heart Failure Patients with LBBB.
Kucio M, et al. · 2025
Transvenous cardiac implantable electronic devices withstand contact sports in an experimental model.
Wegner FK, et al. · 2025
Clinical and echocardiographic outcomes of sync-atrioventricular versus nominal optimization in correlation with QRS narrowing among CRT patients.
Nasr G, et al. · 2025
Case Report of Novel, Automatic Shocking Vector Adjustment Algorithm: A Life-Saving Feature of a Modern Defibrillator.
Heckle MR, et al. · 2022
Interference of cardiac implantable electronic devices and computed tomography imaging in the current era with a phantom model.
Ideishi A, et al. · 2023
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
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