EASYTRAK 2 Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · CRT-Defibrillator (CRT-D) · First cleared Aug 2004 · 3 device variants grouped
Total Reports
232
Reports (30d)
0
Active Signals
0
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Intermittent Loss of Capture on LV Lead
crt, remains service, effects, loss capture, capture
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
FDA recalls for this device
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
Related research
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. · Circulation · 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. · Journal of cardiac failure · 2005
Citations indexed from PubMed.
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