BOSTON SCIENTIFIC CORPORATION · CRT-Defibrillator (CRT-D) · First cleared May 2002
Total Reports
145
Reports (30d)
3
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Left Ventricular Lead Not Capturing
lead explanted, replaced, left ventricular, ventricular lead, capture
6
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
Reduced ventricular volumes and improved systolic function with cardiac resynchronization therapy: a randomized trial comparing simultaneous biventricular pacing, sequential biventricular pacing, and left ventricular pacing.
Rao RK, et al. · 2007
A comparison of cardiac resynchronization by sequential biventricular pacing and left ventricular pacing to simultaneous biventricular pacing: rationale and design of the DECREASE-HF clinical trial.
De Lurgio DB, et al. · 2005
Use of a quadripolar left ventricular lead to achieve successful implantation in patients with previous failed attempts at cardiac resynchronization therapy.
Shetty AK, et al. · 2011
Impact of VV optimization in relation to left ventricular lead position: an acute haemodynamic study.
Khan FZ, et al. · 2011
Spectral Analysis and Mutual Information Estimation of Left and Right Intracardiac Electrograms during Ventricular Fibrillation
Milton Fabricio Pérez Gutiérrez, et al. · Sensors · 2020
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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