SYNERGY Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Coronary Drug-Eluting Stent · First cleared Oct 2015
Total Reports
6,095
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
RV Lead High Impedance Detected
synergy, non bsc, bsc, shaft, advanced treatment
40
reports
Cardiac Arrest After Stent Deployment
death, promus, synergy, experienced, patients
9
reports
RA Lead Not Used Due to Unstable Thresholds
dissection occurred, promus, synergy, edge dissection, stable
7
reports
RA Lead Dislodged and Replaced
synergy, residual stenosis, timi flow, aspirin, prior
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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