EASYTRAK 2 IS-1 Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · CRT-Defibrillator (CRT-D) · First cleared Aug 2004 · 3 device variants grouped
Total Reports
1,032
Reports (30d)
5
Active Signals
2
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Dislodged Left Ventricular Lead
left, lead, replaced, left ventricular, ventricular lead
8
reports
High Out of Range Shock Impedance Alert
measurements, crt, lead, impedance, range
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
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
Citations indexed from PubMed.
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