BOSTON SCIENTIFIC CORPORATION · CRT-Defibrillator (CRT-D) · First cleared May 2002
Total Reports
473
Reports (30d)
29
Active Signals
2
Open Recalls
1
What the reports describe · Claripulse analysis
Noise and Oversensing on Atrial Channel
defibrillator crt, crt, effects, service, therapy defibrillator
8
reports
CRT Revision Due to Infection
crt, crt revision, infection additional, reported crt, revision infection
8
reports
Inappropriate Therapy Delivered for Atrial Rhythm
crt, remains service, therapy, tachycardia, delivered
8
reports
CRT Revision for Infection
crt revision, infection additional, reported crt, revision infection, crt explanted
6
reports
Difficulty Interrogating CRT Device
resynchronization, defibrillator crt, crt, resynchronization therapy, therapy defibrillator
5
reports
Farfield Oversensing Leading to Atrial Response
defibrillator crt, crt, remains service, effects, therapy defibrillator
5
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
Jul 7, 2022 · Open, Classified
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
Evidence
Usefulness of Multisite Ventricular Pacing in Nonresponders to Cardiac Resynchronization Therapy
Samir Saba, et al. · The American Journal of Cardiology · 2021
Prediction of Heart Failure Events With the HeartLogic Algorithm: Real-World Validation
Jagmeet Singh, et al. · Journal of Cardiac Failure · 2023
Comparative Diagnostic Efficacy of HeartLogic and TriageHF Algorithms in Remote Monitoring of Heart Failure: A Cohort Study
David Ledesma Oloriz, et al. · Journal of Cardiovascular Development and Disease · 2025
Implantable Cardioverter Defibrillator Multisensor Monitoring during Home Confinement Caused by the COVID-19 Pandemic
Matteo Ziacchi, et al. · Biology · 2022
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. 2 active signals detected right now.
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