EASYTRAK 2 IS-1 Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · CRT-Defibrillator (CRT-D) · First cleared May 2002
Total Reports
598
Reports (30d)
2
Active Signals
0
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Dislodged Left Ventricular Lead
left, lead, replaced, left ventricular, ventricular lead
5
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
Snare technique for coronary sinus cannulation in cardiac resynchronization therapy
Daniel Höfer, et al. · Indian Pacing and Electrophysiology Journal · 2020
Cerclage parahisian septal pacing through the septal perforator branch of the great cardiac vein: Bedside-to-bench development of a novel technique and lead.
Cho MS, et al. · Heart rhythm · 2019
Citations indexed from PubMed.
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