RV LEAD Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Permanent Defibrillator Electrode (Lead)
Total Reports
255
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Gradual Rise in Shock Impedance Measurements
measurements, shock, technical services, shock impedance, services
2
reports
Lead Capped for Performance Issue
lead capped, effects, service, additional adverse, performance
1
reports
Lead Revision Due to Infection
explanted right, infection additional, revision infection, additional adverse, lead revision
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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